Media

CRG Recruitment Services Ensure NephroGenex Diabetic Nephropathy Study Ahead of Schedule Enrollment Success

Philadelphia, PA, September 16, 2009. Clinical Research Group, Inc. (CRG), a risk- sharing patient recruitment company, announced today that their recruitment strategies helped ensure subject enrollment was completed ahead of schedule and under budget in a diabetic nephropathy study for NephroGenex, Inc., an innovative biotechnology sponsor.

CRG provided a variety of site-customized patient recruitment and retention services for 43 US sites that contributed to the global enrollment of 317 subjects in less than nine months. The core components of the recruitment plan were: primary and secondary market research-based enrollment planning; customized local and in-site initiatives including proprietary study staff recognition programs, a specialty population direct to patient/physician in-site campaign, a grass roots community campaign, a physician cooperation program and facilitation of in-site patient identification; a subject support/retention program; Internet advertising initiatives including a study-specific website, a Pay-Per-Click search engine advertising campaign supported by CRG’s 24/7 metrics; all supported by CRG’s in-house creative development, branding, production and distribution of site-customized materials.

“NephroGenex was fortunate to have had the opportunity to work with CRG. The level of professionalism and cooperation that CRG exhibited throughout this demanding enrollment period was remarkable. With CRG’s leadership, the team stayed focused on the recruitment objectives and overcame a number of hurdles to successfully meet the enrollment goals. We look forward to ongoing collaborations with CRG in the years ahead,” said J. Wesley Fox, Ph.D., NephroGenex’s President and CEO.

“We are grateful to NephroGenex for providing CRG with the strategic opportunity to make a real difference helping to combat kidney disease, while collaborating with a first-class clinical research team,” said Lynn S. Bachrach, CRG’s President and CEO.

About NephroGenex, Inc.

NephroGenex is a drug development company focusing on kidney disease. More than 20 million Americans have some form of chronic kidney disease, and over 400,000 in the US have end stage renal disease requiring dialysis, making renal disease one of the costliest illnesses to treat. The Company is developing Pyridorin™ (pyridoxamine dihydrochloride) as a treatment to slow the progressions of diabetic kidney disease. Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase IIa clinical trials, and has been awarded Fast Track status by the FDA. Pyridorin™ is one of only a few drug candidates in advanced clinical trials for diabetic kidney disease, and possesses a distinctly new mechanism of action over currently approved treatments.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on about 175 protocols in most all therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

Kidney Disease Specialist Establishes a Strategic Alliance with CRG to Provide a Comprehensive Site-Customized Patient Recruitment Program

Philadelphia, PA, February 23, 2009. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it will provide a full service patient recruitment strategic plan to ensure and accelerate patient enrollment in nine months for an innovative biotechnology sponsor of a diabetic nephropathy study.

CRG is providing a variety of site-customized patient recruitment and retention services for approximately 45 US sites to ensure the enrollment of 200 subjects in nine months. The core components of the recruitment plan are: primary and secondary market research-based enrollment planning; customized local and in-site initiatives including proprietary study staff recognition programs, a specialty population direct to patient/physician in-site campaign, a grass roots community campaign, a physician cooperation program and facilitation of in-site patient identification; a subject support/retention program; and Internet advertising initiatives including a study-specific website and a Pay-Per-Click campaign.

“We are particularly excited about having the opportunity to work with this biotech company because we see opportunities where the partnering of our market research core competency with the biotech’s expertise will help crystallize creative approaches to identifying potential patients and we anticipate being able to make a real difference in the success of this biotech helping to combat kidney disease,” said Lynn S. Bachrach, CRG’s President and CEO.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on about 175 protocols in most all therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

Clinical Research Group, Inc. Celebrates 16th Anniversary

Philadelphia, PA, February 9, 2009. On February 9, 1993, Clinical Research Group, Inc. (CRG) opened for business to eager sponsors of clinical trials. 16 years later, those and more eager sponsors are still there.

“We started as a boutique firm in the Philadelphia area,” said Lynn S. Bachrach, President and CEO of CRG. “We thought we could provide specialized recruitment services that showcased our creative, high quality solutions. We started our business with core competencies in recruiting patients to outpatient facilities and market research, but we had never been in the clinical research patient recruitment business before. So it was probably our “outsider perspective” that helped us to be successful. And, we started in one of the most challenging therapeutic areas – oncology. We created an extensive suite of proprietary services based on high quality research and customized materials at a good value. From inception, CRG has always believed that we get better results and as a central part of our culture we have always done business as risk-sharing partners with our sponsors. Combined with our willingness to listen to clients and research sites, this allowed us to build a great patient recruitment company. In fact, without a dedicated sales force, we are grateful that our business has steadily grown based on word-of-mouth endorsements from satisfied clients. Our challenge for all of these years has been to continually develop innovative ways to recruit patients. This operating philosophy has kept the model fresh and exciting for 16 years, and will continue to serve us well into the future.”

CRG is recognized as a patient recruitment thought leader with sustained results in varied protocols and industry-leading productivity metrics. Initially, many skeptics did not believe the CRG model of highly customized recruitment programs was feasible, given its high degree of customization and operational complexity. CRG has collaborated for ahead-of- schedule and under budget successes with most of the major pharmaceuticals as well as many medium- sized and biotechs on about 175 protocols in more than 20 therapeutic areas, in 17 countries with 12 languages. As many as 11 new protocols are expected to be managed during 2009, of which two have already begun as of this date. Company management believes there is room for at least five more studies of various types and sizes to be managed in the latter part of 2009.

“On this special day for our Company, we also want to express our sincere appreciation to our sponsors, staff members and suppliers for their continuing support as partners in our growth,” said Bachrach. “We are convinced the next 16 years should be the best years ever for Clinical Research Group, Inc.”

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on about 175 protocols in most all therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG Recruitment Services Ensure On-time Enrollment Success of Post Herpetic Neuralgia (PHN) Trial

Philadelphia, PA, October 6, 2008. Clinical Research Group, Inc. (CRG), a risk- sharing patient recruitment company, announced today that their full complement of recruitment strategies ensured subject enrollment was completed on schedule for a large pharmaceutical sponsor of a PHN study.

CRG provided a variety of site-customized patient recruitment and retention services specifically designed for an older patient population. The services included primary and secondary market-research based enrollment planning; a comprehensive central advertising campaign including a TV, radio and print campaign and a pay-per-click search engine advertising campaign, with study- specific website and Internet initiatives supported by CRG’s centralized call center with 24/7 metrics, including creative development, branding, production and distribution of site- customized materials and media buying; CRG’s in-site proprietary study staff programs including development of substantial referral networks for all US sites, community outreach programs and subject retention programs for 27 US sites for enrollment of 90 subjects in eight months.

“We were pleased to again meet and exceed the expectations of this key Sponsor and use our experienced insight and recruitment tools to ensure another on- time enrollment success in this important therapeutic area,” said Chris A. Herman, MS, CRG’s Vice President.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG to Provide Recruitment Services to One of the World’s Largest Sponsors

Philadelphia, PA, Sept 9, 2008. Clinical Research Group, Inc. (CRG), a risk- sharing patient recruitment company, announced today that it will provide a full complement of recruitment strategies to ensure subject enrollment ahead of schedule for a large pharmaceutical sponsor of a gastroenterology study.

CRG is providing a variety of site- customized patient recruitment and retention services. The services include primary and secondary market-research based enrollment planning; a comprehensive central advertising campaign including a radio and print campaign along with a direct mail campaign and a pay-per-click search engine advertising campaign, with study- specific website and Internet initiatives supported by CRG’s centralized call center with 24/7 metrics, including creative development, branding, production and distribution of site- customized materials and media buying; CRG’s in-site proprietary study staff programs including development of substantial referral networks for all US sites, community outreach programs and subject retention programs for 25 US sites to enroll 100 subjects in three months.

“We are excited about the opportunity to continue our long-term collaboration with this key Sponsor and use some of our exciting new tools to ensure another ahead-of or on- time enrollment success in this important therapeutic area,” said Chris A. Herman, MS, CRG’s Vice President.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG Inks a Master Services Agreement with a Large Pharmaceutical Company

Philadelphia, PA, June 23, 2008. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that a large pharmaceutical company has signed a Master Services Agreement with CRG to help ensure completion of multiple clinical trials ahead of plan and under budget.

CRG is providing a variety of site-customized patient recruitment and retention services. The services include primary and secondary market-research based enrollment planning; site identification and qualification from CRG’s largest-in-industry database of researchers; a comprehensive central advertising campaign with study-specific website and Internet initiatives supported by CRG’s centralized call center with 24/7 metrics, including creative development, branding, production and distribution of site- customized materials and media buying; CRG’s in- site proprietary programs, community outreach programs and subject retention programs.

“We are grateful for this continued opportunity to extend our successful collaboration with this large pharmaceutical sponsor,” said Lynn S. Bachrach, CRG’s President and CEO, “with this exciting Master Services Agreement.”

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG Helps Large Sponsor Complete Study in Half Projected Time

Philadelphia, PA, May 20, 2008. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it has collaborated with a large pharmaceutical sponsor to help complete a Phase III multinational study six months ahead of schedule in a one-year planned study.

CRG provided a variety of site-customized patient recruitment and retention services. The services included primary and secondary market-research based enrollment planning; a comprehensive international, central advertising campaign with study- specific website and Internet initiatives supported by CRG’s centralized call center with 24/7 metrics, including creative development, branding, production and distribution of site-customized materials and media buying; and subject retention programs for 90 US and 14 Rest of World sites to enroll 550 subjects in six months.

“We are grateful to have had this exciting opportunity to help accelerate the completion of this important trial and for the continued collaborations with this large sponsor,” said Lynn S. Bachrach, CRG’s President and CEO.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

One of the World’s Largest Pharma Companies Collaborates with CRG to Complete Trials Early and Under Budget

Philadelphia, PA, September 25, 2007. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that one of the world’s largest pharmaceutical companies has established an alliance with CRG to help ensure completion of its oncology clinical trials ahead of plan and under budget.

CRG is providing a variety of site-customized patient recruitment and retention services. The services include primary and secondary market-research based enrollment planning, a variety of CRG’s in-site proprietary programs, site selection and regulatory credentialing from CRG’s best in class network of top-enrolling oncology sites, Oncology Research Group (ORG), and subject retention programs.

“We are thrilled to have an opportunity to collaborate with this one of the world’s largest sponsors in oncology where we have such a long track record of providing a competitive enrollment advantage,” said Lynn S. Bachrach, CRG’s President and CEO, “so that together we can make a contribution to getting needed drugs available sooner.”

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media-based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG Helps One of the World’s Largest Sponsors Complete a Women’s Health Study Ahead of Schedule and Under Budget

Philadelphia, PA, June 26, 2007. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it has collaborated with one of the world’s largest pharmaceutical sponsors to help complete a phase IIB multinational women’s health study ahead of schedule and under budget.

CRG collaborated with this large sponsor client to help overcome very aggressive timeline challenges by providing site-customized patient recruitment services. The services included media development and placement, recruitment metrics, centralized call center, and in-site support programs for over 50 US participating sites and over 300 evaluable subjects. CRG has successfully collaborated with this large pharma on 16 trials over the last 13 years in three therapeutic areas -oncology, women’s health and HIV.

“In light of the pressing need for effective non-hormonal women’s health solutions, we are particularly gratified to have had this continuing opportunity to collaborate with this large sponsor,” said Lynn S. Bachrach, CRG’s President and CEO.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media-based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG to Present Webinar, “Three Simple Solutions to Accelerating Trial Completion”
June 19, 2007 @ 1:00 – 1:30 pm EDT

Philadelphia, PA June 5, 2007. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today it will present a Webinar in conjunction with Xtalks, Three Simple Solutions to Accelerating Trial Completion.

Why do clinical trials miss enrollment timeline goals and how can we turn this around and ensure that we complete enrollment on-time? CRG has 14 years of successful collaboration in bringing in trials early and under budget with most of the major pharmaceuticals and many biotechs on over 150 protocols in a variety of therapeutic areas. We have condensed our experience and we’re sharing the three key tenets to our success in this Webinar. Please join us in this free Webinar to hear our insights and solutions.

This program is intended for anybody responsible for meeting clinical trial timelines and budgets within the pharma and biotech industries; including: Outsourcing, Project Management and Clinical Development.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

Learn more about CRG.

About the Speakers

Lynn S. Bachrach, President and CEO

Lynn S. Bachrach has 25 years of entrepreneurial experience including two business start-ups and running a public company. As Founder, President and CEO of CRG, she is very committed to providing ahead-of-schedule and under budget results on a risk- sharing basis with partner clients. Lynn started The Cardiac Rehab Company in 1989 and CRG in 1993. Before that, she was President and Senior Vice- President of C.P. Rehab Corp., and Senior Vice- President of C.P. Rehab Corp Midlantic. Earlier, she won recognition as the top salesperson for Datamedix Inc. and Meloy Laboratories. She earned her BA in Psychology from Antioch College.

Harry Bachrach, Principal and CFO

Harry Bachrach is a founder of CRG and another associated company. He is recognized as an innovative thought leader in patient recruitment. As Principal and CFO, he leads the company with regards to all key strategic, financial, and operational issues, and takes a personal interest in ensuring that CRG’s database of community and other researchers in select major therapeutic areas is the best in the industry. Prior to CRG, he had responsibilities for biological manufacturing and veterinary services at Merck Manufacturing Division. Harry earned his BS in Mechanical Engineering from Drexel University.

Vicky Rochford, Senior Vice President

Vicky Rochford has 20 years of clinical and management experience and is CRG’s Senior Vice President and a company founder. She leads the development and implementation of our successful patient recruitment programs and also plays a key leadership role in business development and strategy. Prior to CRG, Vicky was involved in a consistently top enrolling independent outpatient research facility. Earlier, she was Vice President of Clinical Services for C.P. Rehab Corp. In addition, she has been a Cardiovascular Nurse Specialist and the Supervisor of an ICU/CCU. Vicky earned her Degree in Nursing with Honors from Sinclair College.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Helps Fujirebio Diagnostics, Inc. Complete Enrollment Goal Two Weeks Early and 63% Under Budget

Philadelphia, PA, February 5, 2007. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it helped Fujirebio Diagnostics, Inc. (FDI), a world leader in in-vitro diagnostics, successfully complete its midterm goals of 400 enrolled subjects in a bladder cancer assay study, two weeks ahead of plan and 63% under budget.

“We attribute the rapid completion of the midterm goals in this study to a combination of promising technology coupled with CRG’s cutting-edge patient recruitment programs that greatly supported our team’s efforts,” said W. Jeffrey Allard, Ph.D., Vice President and Chief Scientific Officer of FDI.

CRG provided a proprietary patient recruitment program for multiple participating US sites, as well as in-site advertising, site selection and recruitment metrics.

“It is gratifying to be able to help accelerate the potential availability of a non-invasive diagnostic tool focused on estimating the risk of bladder cancer, the fourth most common cancer in men and ninth in women,” said Lynn S. Bachrach, CRG’s President and CEO.

About Fujirebio

Fujirebio Diagnostics, Inc. (FDI) is a premier diagnostics company and the industry leader in tumor market assays. FDI specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. In November 1998, Fujirebio, Inc. of Tokyo, Japan, acquired the company, formerly known as Centocor Diagnostics. Fujirebio Diagnostics utilizes its worldwide distribution network to enable access by physicians and patients to its diagnostic products.

About Clinical Research Group, Inc.

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media-based initiatives with proprietary site-based initiatives for the most cost-effective results.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Establishes Patient Recruitment Strategic Alliance with MannKind Corporation and Completes Pivotal Study One Month Early and Under Budget

Philadelphia, PA November 14, 2006. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it has established a patient recruitment strategic alliance with MannKind Corporation, a company that focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer, and contributed to the successful early completion of the patient recruitment for the strategic alliance’s first pivotal Phase 3 inhaled insulin diabetes study.

“This particular trial posed one of our biggest challenges as it called for enrolling 1,890 patients within a very aggressive timeframe. We attribute the rapid one-month ahead-of-schedule completion of the study to the excitement in the field for our technology supported by CRG’s very effective advertising and proprietary in-site initiatives,” said Dr. Peter Richardson, Chief Scientific Officer of MannKind.

In this patient recruitment strategic alliance, CRG is providing a variety of patient recruitment and support services including proprietary CRG patient recruitment programs to seven MannKind diabetes studies with over 325 sites and close to 2,500 patients.

“We are deeply grateful, tremendously motivated, challenged and excited to have the opportunity to play such an integral role in working with such a dynamic sponsor, whose cutting-edge technology offers so many advantages to patients,” said Lynn S. Bachrach, CRG’s President and CEO.

About Clinical Research Group, Inc.

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media- based initiatives with proprietary site-based initiatives for the most cost-effective results.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Helps One of World’s Largest Sponsors Complete HIV Study Ahead of Schedule and Under Budget

Philadelphia, PA August 25, 2006. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it has collaborated with one of the world’s largest pharmaceutical sponsors to help complete a phase IIB/III multinational HIV study ahead of schedule and under budget.

CRG helped overcome very aggressive timeline challenges by providing site-customized patient recruitment and retention services. The services included media development and placement, recruitment metrics, and its centralized call center for 52 US sites and over 150 evaluable subjects. CRG has successfully collaborated with this large pharma on 15 trials over the last 12 years in three therapeutic areas –oncology, women’s health and HIV.

“In light of the pressing need for effective next generation HIV treatments, we are particularly gratified to have had this continuing opportunity to collaborate with this large sponsor,” said Lynn S. Bachrach, CRG’s President and CEO.

About Clinical Research Group, Inc.

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media-based initiatives with proprietary site-based initiatives for the most cost-effective results.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

Diabetes Sponsor Partners with CRG to Complete Trials Early and Under Budget

Philadelphia, PA June 05, 2006. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that a leading Diabetes Sponsor has established a strategic alliance with CRG to help ensure completion of its trials ahead of plan and under budget.

CRG is providing a variety of patient recruitment and retention services: media development and placement, recruitment metrics, centralized call center, and other proprietary CRG patient recruitment programs. CRG is also developing corporate communication and patient-focused instructional videos.

“We are thrilled by the opportunity to work so closely and make a difference with this dynamic Sponsor and its cutting-edge technology,” said Lynn S. Bachrach, CRG’s President and CEO.

About Clinical Research Group, Inc.

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media-based initiatives with proprietary site-based initiatives for the most cost-effective results.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Helps Acuity Pharmaceuticals to Complete Patient Enrollment in Pioneering Phase II Clinical Trial

Philadelphia, PA May 05, 2006. Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, announced today that it helped Acuity Pharmaceuticals successfully complete patient enrollment in its first Phase II trial for its lead product, Cand5, ahead of plan and under budget.

Acuity Pharmaceuticals, a product-focused ophthalmic pharmaceutical company, recently announced that it has successfully completed patient enrollment and dosing in its Phase II C.A.R.E.(TM) clinical program for Cand5 for the treatment of wet age-related macular degeneration (wet AMD), a leading cause of adult blindness. This was the first- ever Phase II program for a small interfering RNA (siRNA) therapy, an innovative approach based on the powerful gene silencing technology of RNA interference (RNAi).

“We attribute the rapid completion of this trial in a highly competitive marketplace to a combination of our innovative technology coupled with CRG’s cutting- edge patient recruitment programs that greatly supported our team’s efforts,” said Dale Pfost, Ph.D., President and CEO of Acuity.

CRG provided a proprietary patient recruitment program for multiple participating US sites. In addition, CRG provided site selection, recruitment metrics, and a patient retention program. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major pharmaceutical companies over the last 13 years on over 150 protocols in a variety of therapeutic areas.

“It is particularly gratifying to be able to work so closely with such a dynamic team on study drugs based on brilliant science that offer hope to those facing devastating sight loss,” said Lynn S. Bachrach, CRG’s President and CEO.

About Clinical Research Group, Inc.

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has a long track record of success in bringing in clinical studies early and under budget, having worked with most of the major and many medium-sized pharmaceuticals and biotechs on over 150 protocols in a variety of therapeutic areas. CRG differentiates itself in three ways. First, CRG finishes clinical trials at double industry rates. Second, CRG uses risk-sharing fees – meaning they are ‘in this’ with their pharmaceutical partners – winning together. Finally, CRG integrates media-based initiatives with proprietary site-based initiatives for the most cost-effective results. Further information about CRG can be found on the company’s website.

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About Acuity Pharmaceuticals

Founded in 2002, Acuity Pharmaceuticals is a product- focused ophthalmic pharmaceutical company applying its proprietary technology to the treatment and prevention of ophthalmic diseases, focusing initially on leveraging its strong technology and intellectual property portfolio in the field of RNA interference (RNAi). Acuity is developing treatments for age- related macular degeneration (AMD) and diabetic retinopathy (DR), two of the leading causes of adult vision loss in the developed world. Its lead clinical compound Cand5, a small-interfering RNA (siRNA) therapeutic currently in Phase ll trials, shuts down vascular endothelial growth factor (VEGF), which has been shown to be the central stimulus in the development of AMD and DR. In late 2004, Cand5 became the first-ever RNAi therapy to enter human trials. Its novel siRNA mechanism of action is expected to give Cand5 efficacy, safety and administration advantages over other therapies.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

Acuity Pharmaceuticals
Todd M. Wallach
Senior Director, Finance and Operations
(215) 966-6181

CRG Med Dir Chosen to Ride with Lance Armstrong in the Bristol-Myers Squibb Tour of Hope™ for Cancer Research

Philadelphia, PA, July 6, 2005. Clinical Research Group, Inc. (CRG) announced today that its Medical Director, Peter T. Silberstein, MD, has been chosen out of almost 1,100 applicants to be a part of the Bristol-Myers Squibb Tour of Hope™ Team of 24 cyclists to participate with Lance Armstrong in a 9-day journey across America to inform the public about the importance of cancer clinical trials.

The Bristol-Myers Squibb Tour of Hope™ Team will depart San Diego on Thursday, September 29th for its nine-day journey across America to share their powerful stories about the promise of cancer research. The people of San Diego and Scripps Health will come together to greet Lance Armstrong and the 24 riders, and send off the Team who will cycle around the clock until they reach Washington, DC on Saturday, October 8th. The Team will take a southern route across the United States and encourage all they meet to join them in the fight against cancer.

Throughout its journey, the Team will make stops at cancer centers and in communities to encourage people to make the Promise – a personal commitment to learn more about cancer and the benefit of cancer clinical trials. The public will be invited to show support for the Team at various points along the route, as the riders travel through California, Arizona, New Mexico, Texas, Louisiana, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Virginia, Maryland and Washington, DC.

Dr. Silberstein was a young oncologist in 1984 when his father was diagnosed with colon cancer. He died several years later, leaving Dr. Silberstein frustrated that treatments were not able to save his life. Since that time, four new colon cancer drugs have been approved to treat his type of cancer. Dr. Silberstein, CRG’s Medical Director and a company founder, is passionate about enrolling patients on the clinical trials studying these drugs, and has seen patients’ prognoses steadily improve.

It’s a bittersweet feeling for Dr. Silberstein, who was finishing up his oncology fellowship when his father was first diagnosed. “If my father had been given the opportunity to be treated with today’s new drugs, he might possibly still be alive now,” Dr. Silberstein says. “It fills me with joy to see patients today who are alive and flourishing because of these new breakthroughs, and I think with sadness about my father’s tragic death.”

The loss of his father has propelled Dr. Silberstein to be a vigorous advocate for cancer research in the form of clinical trials. “It helped motivate me to use new drugs and clinical trials and to be a founder of CRG, a company dedicated to accelerating the completion of clinical trials and thereby getting the best drugs to patients quicker. I hope we can find breakthroughs that will help other patients so they will not meet the fate of my father,” he says.

He proudly tells the stories of two of his patients, one with leukemia and another with kidney cancer that were cured with therapies only available through clinical trials. “Because of the advances made through clinical research, I’ve seen many patients cured of diseases that previously had been uniformly fatal,” he says.

“In the adult community, only five percent of cancer patients will enroll in a clinical trial, yet sixty percent of children with cancer enter into a clinical trial resulting in much higher success rates in pediatric cancer,” said Lance Armstrong. More than eight years after being diagnosed with advanced testicular cancer, Mr. Armstrong is going for a historical seventh consecutive and final Tour de France title this July. “If we want to advance the science and find a cure for cancer, more people will have to participate in clinical trials.” To learn more about the Bristol-Myers Squibb Tour of Hope™ and how to get involved, visit www.tourofhope.org.

Dr. Silberstein, CRG’s Medical Director and a company founder, is a board-certified Hematologist/Oncologist and has been a practicing physician since 1985. He is the Chief of Hematology/Oncology Division of Creighton University, in Omaha, Nebraska. He earned his B.A. Summa Cum Laude from Amherst College, earned his M.D. with honors from the State University of New York, completed his residency in Internal Medicine from the University of Iowa, and completed his fellowship in Hematology/Oncology from the University of Minnesota.

About Clinical Research Group, Inc. (CRG)

Founded in 1993, privately held and based in Villanova, PA, CRG partners with pharmaceutical companies to help complete enrollment under budget and ahead of schedule. As a risk-sharing patient recruitment company, CRG has worked with most of the major and many medium-sized pharmaceuticals and biotechs. CRG differentiates itself in three ways. First, CRG has more than doubled the rate of completing trials in both new protocols and those in need of rescue. Second, CRG uses risk-sharing fees based on randomized patients, with bonuses and penalties for exceeding or missing those goals. Finally, with its clinically based resources and processes, CRG is effective both with patient-driven protocols where media-based initiatives are cost-effective and physician-driven protocols where having the best sites supported with site initiatives is most effective.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Helps Pharma Complete Trial Early and Under Budget

Philadelphia, PA, June 13, 2005. Clinical Research Group, Inc. (CRG) announced today that it has helped complete enrollment in a Phase III diabetes trial for a world leading pharmaceutical company, in two-thirds of the projected time, using only 78% of the nearly $400,000 budget.

CRG provided site-customized patient recruitment services for 78 US sites and over 330 randomized patients. These services included developing and implementing an advertising campaign and providing site support initiatives, supported by our centralized 24/7 call center.

About CRG

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. CRG has been bringing in projects ahead of schedule and under budget for 12 years. The Company differentiates itself in three ways. First, CRG has more than doubled the rate of completing trials in both new protocols and those in need of rescue, having worked with 140 protocols from most of the major and many medium-sized pharmaceuticals and biotechs. Second, CRG uses risk-sharing fees based on randomized patients, with bonuses and penalties for exceeding or missing those goals. Finally, with its clinically based resources and processes, CRG is effective both with patient-driven protocols where media-based initiatives are cost-effective and physician-driven protocols where having the best sites supported with site initiatives is most effective.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Accelerates Enrollment Completion in Non-HRT Women’s Health Trial

Philadelphia, PA, December 3, 2004. Clinical Research Group, Inc. (CRG) announced today that it has completed recruitment one month ahead of schedule in a women’s health trial for one of the world’s largest pharmaceutical companies. In this Phase IIA proof of concept trial, almost 300 subjects with moderate to severe menopausal symptoms were recruited from 33 US sites in four months of the projected five month enrollment period.

Based on CRG’s performance in earlier trials and the urgent nature of this study, CRG was awarded a sole source contract to provide the patient recruitment services. This is the fourth such trial in the past two years in which CRG has worked with the same Sponsor to accelerate trial completion.

“In light of women’s needs for effective alternatives to HRT [hormone replacement therapy], we are particularly gratified to have this continuing opportunity to collaborate with this leading sponsor,” said Lynn S. Bachrach, President & CEO of CRG.

About Clinical Research Group, Inc. (CRG)

Founded in 1993, privately held and based in Villanova, PA, CRG is a risk-sharing patient recruitment company. The Company differentiates itself in three ways. First, CRG has provided a CRG Trial Acceleration Factor of >200% to site activation-readiness and study enrollment completion in both new protocols and those in need of rescue, for almost 140 protocols in 11 years, with most of the major and many medium-sized pharmaceuticals and biotechs. Second, CRG uses risk-sharing fees based on randomized patients, with bonuses and penalties for exceeding or missing those goals. Finally, with its clinically based resources and processes, CRG is effective both with patient-driven protocols where media-based initiatives are cost-effective and physician-driven protocols where having the best sites supported with site initiatives is most effective.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Helps Accelerate Trial Completion in More Than 130 Protocols

Philadelphia, PA, August 17, 2004. Clinical Research Group, Inc. (CRG), the leading Trial Acceleration Management Organization (TAMO) in North America, announced today that since its inception, it has provided trial acceleration services for more than 130 protocols.

This is what sets CRG apart:

Documented CRG Enrollment Accelerator Factor >200%.
Documented CRG Trial Start-up Accelerator Factor >200%.
Risk-sharing fees, with bonuses and penalties for exceeding/missing goals.
Trial Acceleration Management Organization (TAMO) model provides proven effective strategies for both physician-driven and patient-driven studies.
“It has been exciting to help so many large and small pharmaceutical and biotechnology companies lower drug development costs by speeding up their drug development processes,” said Lynn S. Bachrach, President and CEO of CRG. “Further, it is gratifying to know that we are helping to expedite the availability of life-saving drugs for patients in need.”

The therapeutic areas covered by the more than 130 protocols include:

Cardiology
Dermatology
Devices
Endocrinology
Gastroenterology
Healthy Patient Studies
Infectious Diseases
Nephrology/Urology
Neurology
Oncology
Orthopedics
Psychiatry
Pulmonary/Respiratory
Rheumatology
Sexually Transmitted Diseases
Women’s Health
About Clinical Research Group, Inc. (CRG)
Founded in 1993, privately held and based in Villanova, PA, CRG helps lower drug development costs by accelerating trial start-up and completion. Having effectively integrated its disease specific networks with the creative and strategic capabilities of a patient recruitment and market research firm, CRG is recognized as the leading risk-sharing North American Trial Acceleration Management Organization (TAMO). CRG has earned a documented track record of providing a CRG Enrollment Accelerator Factor of >200% to site activation-readiness and study enrollment completion in both new protocols and those in need of rescue.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)

CRG Awarded Sole Source Contract

Philadelphia, PA, July 20, 2004. Clinical Research Group, Inc. (CRG) announced today that it has been awarded a sole source contract with one of the world’s largest pharmaceutical companies to manage patient recruitment in a women’s health trial. This is the third women’s health trial in the past two years in which CRG has worked with the same Sponsor to accelerate trial completion. In the most recent trial, over 700 subjects were recruited in almost half of the projected six-month enrollment period, using less than half of the advertising budget.

Based on CRG’s ahead of schedule and under-budget contributions in the earlier trials and the urgent nature of this trial, CRG has been selected to provide the patient recruitment services for this trial in a sole source contract. The compound will be tested in a Phase IIA proof of concept trial of almost 300 subjects. The recruitment plan calls for providing site-customized enrollment support and patient recruitment initiatives for the five-month enrollment period. The trial will be conducted at 35 US sites.

“We are thrilled to have this continued opportunity to help this key client accelerate trial completion of this exciting compound that may offer real benefits to many women,” said Lynn S. Bachrach, President & CEO of CRG. “

About Clinical Research Group, Inc. (CRG)

Founded in 1993, privately held and based in Villanova, PA, CRG helps lower drug development costs by accelerating trial start-up and completion. Having effectively integrated its disease specific networks with the creative and strategic capabilities of a patient recruitment and market research firm, CRG is recognized as the leading risk-sharing North American Trial Acceleration Management Organization (TAMO). CRG has earned a documented track record of providing a CRG Enrollment Accelerator Factor of >200% to site activation-readiness and study enrollment completion in both new protocols and those in need of rescue.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Provides 400% Enrollment Accelerator Factor

Philadelphia, PA, February 20, 2004. Clinical Research Group, Inc. (CRG) provided a 400% Enrollment Accelerator Factor to a phase II women’s health study for one of the world’s largest pharmaceutical companies. This was accomplished by providing site-customized enrollment support and patient recruitment initiatives in the last five months of the 18-month study. The enrollment rate was increased from an average of 13 patients per month to 54 patients per month with no change in the number of sites. The Sponsor has now moved into the expanded phase III trial. Based on CRG’s proven performance, both with results and responsiveness, CRG was selected out of four patient recruitment firms to support enrollment for all 98 North American sites (83 US and 15 Canadian). With CRG’s help, the phase III trial is already considerably ahead of enrollment goals.

“We are thrilled to have this continued opportunity to contribute to the early completion of this very exciting research,” said Lynn S. Bachrach, President & CEO of CRG. “This emphasizes the strategic importance of CRG’s site-customized enrollment support and patient recruitment initiatives to CRG’s continued contributions to lowering the cost of drug development costs through trial acceleration.”

About Clinical Research Group, Inc. (CRG)

Founded in 1993, privately held and based in Villanova, PA, CRG helps lower drug development costs by accelerating trial start-up and completion. Having effectively integrated its disease specific networks with the creative and strategic capabilities of a patient recruitment and market research firm, CRG is recognized as the leading risk-sharing North American Trial Acceleration Management Organization (TAMO). CRG has earned a documented track record of providing a CRG Enrollment Accelerator Factor of >200% to site activation-readiness and study enrollment completion in both new protocols and those in need of rescue.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

CRG Facilitates Early Completion of Patient Enrollment in Phase III Anal Dysplasia Trial

VILLANOVA, PA, August 2, 2001. Clinical Research Group, Inc. (CRG) announced today that patient enrollment has reached its target ahead of schedule in Stressgen Biotechnologies Corporation’s Phase III clinical trial investigating a novel immunotherapeutic for anal dysplasia (AIN) caused by human papillomavirus (HPV).

This randomized, double-blind, placebo-controlled study initiated patient treatment in November 2000 and completed enrollment of 128 patients at multiple study centers in the United States. Enrollment was completed two months ahead of the Company’s originally projected schedule.

CRG was responsible for market research-based enrollment planning, investigator and site selection and enrollment support initiatives. Since research and treatment in anal dysplasia (AIN) is still in its infancy, CRG did extensive site development and staff training to help prepare investigative sites for this Phase III trial and for its Phase II predecessor.

“With the goal of getting drugs to the marketplace as quickly as possible, we depend on the performance of competent external consultants,” said John R. Neefe, M.D., Vice President, Clinical Research and Regulatory Affairs at Stressgen. “CRG played a pivotal role in completing patient enrollment in our Phase III AIN trial two months ahead of schedule, an accomplishment achieved because of their hard work and determination.”

“Stressgen is one of our most important clients,” said Lynn S. Bachrach, President and CEO of CRG. “We are very pleased to continue to have the opportunity to collaborate with Stressgen and help accelerate its exciting, cutting-edge research in the field of HPV-related diseases.”

Founded in 1993, CRG is a privately held, specialized contract research organization (CRO) based in Villanova, PA that focuses on the acceleration of the completion of clinical research trials. CRG has earned a track record of identifying sites, completing regulatory packages and enrolling patients more than twice as quickly as the standard industry rates. CRG’s fees are structured on results rather than time.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

Perceived Industry Impact of Recent Recalls and Warnings

Clinical Research Group, Inc. (CRG), a risk-sharing patient recruitment company, contacted 12,556 people in the pharmaceutical industry to assess the perceived impact of the recent recalls and warnings. The market research results show consensus on many of the issues and provide some very stimulating suggestions.

Below are brief descriptions and charts summarizing the responses to each of the 14 questions, including the last two open-ended write-in questions addressing anticipated and recommended changes.

1. “What are your researchers relaying to you about how their patients are reacting?”

Although the largest percentage of respondents indicated they had no feedback from their researchers on this question, for those that did have feedback, over 80% said there was some increase in wariness of patients about prescription drugs and/or trials.

2. “What impact to your sales of all your major products have you seen?”

Almost 90% of respondents indicated that there was, at minimum, no impact on sales of major products, or even an increase in sales.

3. “What effect to your stock value have you seen?”

Almost 75% of respondents indicated that there was, at minimum, no impact on stock value, or even an increase in sales.

4. “How long do you anticipate this reaction by your major drug purchasers to last?”

Although almost half indicated that the question was not applicable, for those that did indicate a time, almost 85% said it would last at least six months.

5. “Do you anticipate major pharma having any dampening of their access to capital for R&D?”

Over 90% of the respondents said the impact would be modest or none.

6. “Do you anticipate bio-pharma and start-up companies having any dampening on their access to capital for R&D, particularly venture capital?”

Over 80% of the respondents said the impact would be modest or none.

7. “Has your confidence in your job security changed?”

Almost 80% of the respondents said there was either no change or less concern about job security.

8. “Do you anticipate that the credibility/litigation involved in these recalls and warnings will stifle patients volunteering for clinical research?”

Almost 90% of the respondents said there would be a modest impact at most on volunteering for clinical research.

9. “How effective do you feel the industry is currently in addressing the public’s concerns about drug safety and testing through addressing this directly in advertisements?”

Almost 90% of the respondents said that the industry needs to do more about addressing the public’s concerns.

10. “How has your funding for patient recruitment changed over the last year?”

Almost 90% of the respondents said that patient recruitment funding either has not changed at all or has increased in the last year.

11. “How do you feel funding for patient recruitment in your future projects will be impacted?”

Almost 90% of the respondents said that patient recruitment funding either would not change at all or would increase in the future.

12. “Do you feel COX-2 inhibitors have value or a future?”

Almost 90% of the respondents said that they feel COX-2 inhibitors have a modest or significant value or future.

13. “Do you foresee any congressional or agency changes to the development and testing regulations?”

67% of the respondents indicated that they foresee congressional or agency changes to the development and testing regulations. They foresee changes in three key categories (examples):

1.Restructure Pharma and FDA and Drug Approval Process: 56% see that pharma, the FDA, and the drug approval process will be restructured: 25% believe that drug approval procedures will be revised; 20% believe that there will be additional legislation, government/FDA regulations, or FDA reorganization; and 11% believe that extended post- approval pharmacovigilance will be developed.

2.Improve Clinical Trial Process: 34% believe that the clinical trial process will be improved: 14% believe we will see larger and longer trials; 12% believe that there will be increased safety testing; and 8% believe that the number and scope of Phase IV trials will be increased.

3.Improve Communications: 9% believe that communications will be improved: 3% believe that the public perception of the industry will be addressed; 2% believe that we will have full disclosure of all trial results; 2% believe we will address direct-to-consumer advertising, and 2% believe we will increase awareness of Adverse Events and side effects.

4. “Are there any additional improvements to the drug development and testing procedures that you would suggest?”

56% of the respondents suggested other improvements to the drug development and testing procedures. Their recommendations were also in the same three key categories as Question #13 above (examples):

1.Restructure Pharma and FDA and Drug Approval Process: 54% see that pharma, the FDA, and the drug approval process need to be restructured: 18% believe that the drug approval procedures need to be revised; 18% believe that enhanced training is needed; 13% believe that extended post-approval pharmacovigilance is needed; and 5% believe that additional legislation, government/FDA regulations, or FDA reorganization is needed.

2.Improve Clinical Trial Process: 24% believe that the clinical trial process needs to be improved: 10% believe that increased safety testing is needed, 7% believe we need to increase the number and scope of Phase IV trials, and 6% believe that we need larger and longer trials.

3.Improve Communications: 23% believe that communications need to be improved: 9% believe we need to increase awareness of Adverse Events and side effects, 5% believe we need to address the public perception of the industry, 5% believe we need to address direct-to-consumer advertising, and 4% believe we need full disclosure of all trial results.

In summary, we believe that this market research indicates that the industry perceives that:

1.the industry is, overall, financially stable.

2.although changes in testing and regulatory procedures are needed, clinical research will continue generally at, or above, previously funded levels.

Survey responses have a margin of error of plus or minus 6%, calculated at the 95% confidence level.

This page © Copyright 2005 by Clinical Research Group, Inc. (CRG)

For additional information about CRG please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

Special Profile Reprint Clinical Research Group, Inc. (CRG) Villanova, Pa.

An interview with Lynn S. Bachrach, President and CEO

Year founded: 1993
Employees: 19
Offices: 2
Active projects: 7
Tel: (610) 527-6417 x 201
Web site

When you have a physician-driven protocol, you need the best sites—that’s a critical part of it—and then you also need to support those sites with other kinds of initiatives that work within the sites.

What are your plans for growth?

We’ve grown predominantly with our own resources. We’ve survived 9/11 and the recession and in getting through all of that, we’ve gotten stronger and smarter. We feel that we’ve come to this patient recruitment marketplace with a unique background based on over a decade of experience with enrolling in very challenging trials such as oncology and in having a different type of company culture that is deeply rooted in a commitment toward risk-sharing. We have steady pipelines of business from some of the world’s largest pharma. Our plan is to continue on this path of providing risk-sharing patient recruitment services so that we become a dominant patient recruitment firm that continues to make a real impact on lowering the cost of drug development by accelerating trial startup and completion.

What is CRG’s background?

The vision that the four founders of CRG had was to use the synergy of our combined proven experience and capabilities to create a company that would add value for pharmaceutical clients in a risk-sharing way while enhancing the lives of clients and employees. Based on that, we started out as an oncology-based management group focused on providing top-enrolling investigators to sponsors. In 1996, we coalesced our top-enrolling oncology researchers into our first therapeutic area network and other therapeutic area networks followed. Then, based on our commitment to making sure that we always get better results for our clients, we expanded and in 1999 we added patient recruitment and market research services. Now, we have fully evolved into a risk-sharing patient recruitment company.

What differentiates CRG from other patient recruitment companies?

There are three key things that differentiate CRG from other patient recruitment companies. The first is that we have earned a documented CRG trial acceleration factor of greater than 200%. This applies to site activation readiness as well as study enrollment completion in both new protocols and those in need of rescue. The second is that our fees are risk-sharing fees based on randomized patients. We get bonuses and penalties for exceeding or missing those goals. The third is that with our clinically based history, our resources and processes are effective both with patient-driven protocols for which media-based initiatives are cost-effective and also with physician-driven protocols for which choosing the best sites supported with lower tech site-customized enrollment initiatives are most effective.

We spent so many of our early years working predominantly in oncology. Those protocols are always challenging to enroll and it helped challenge us to develop effective enrollment initiatives. If you look at all the protocols out there, about half are responsive to advertising or are patient-driven and about half are physician-driven. When you can use the advertising it’s the most powerful, but for 50% of the protocols you can use it and spend an extraordinary amount of money but it’s not going to give you the return. It’s not the way to drive enrollment in a protocol where you’re dealing with those diseases that are life-threatening and patients don’t have a lot of energy and they’re generally not going to be changing doctors.

CWWeekly (ISSN 1528-5731)

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From Volume 8, Issue 46. November 15, 2004. Copyright © 2004 by Thomson CenterWatch. All rights reserved.

CRG “helps lower drug development costs by accelerating trial start-up and completion.”

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG) 

Study Suggests Recruitment Advertising in Research May be Lacking Regulatory Compliance

DENVER, CO, July 10, 2001. Clinical Research Group, Inc. (CRG) announced at the Drug Information Association’s 2001 Annual Meeting results from a study conducted in 2000 that demonstrated that less than half of recruitment advertising for clinical trial patients may actually be in regulatory compliance.

The four-month study was conducted by Charles Schweizer, MS, as research at the Philadelphia College of Pharmacy and Science. The purpose of the study was to examine the prevalence of patient recruitment advertising that is non-compliant with FDA regulatory guidelines as set forth in the 1998 Information Sheets. These guidelines generally state that recruitment advertising should not make safety claims, efficacy claims, use “new” or “free treatment”, or emphasis on payment. Only 43% of the ads sampled were compliant. The rationale in regulating the use of such terms is that these regulations will help protect human research subjects from being coerced into study participation.

“Regulatory compliance in recruitment advertising is a crucial part of assuring the protection of research subjects,” said lead researcher Charles Schweizer, MS, Director of Operations at CRG. “This study suggests that the high prevalence of recruitment materials that are non-compliant may be compromising this protection. Professionals involved in promoting research studies need to take steps to be certain that compliance is met,” he added.

Lynn S. Bachrach, President and CEO of CRG, stated, “We consider these types of studies vital to CRG’s commitment to finding innovative ways to accelerate clinical trials while ensuring research integrity. As the practice of patient recruitment continues to expand, expertise in the integration of study marketing and regulatory compliance will become an integral part of a successful clinical trial.”

Founded in 1993, CRG is a privately held, specialized contract research organization (CRO) based in Villanova, PA that focuses on the acceleration of the completion of clinical research trials. CRG has earned a track record of identifying sites, completing regulatory packages and enrolling patients more than twice as quickly as the standard industry rates. CRG’s fees are structured on results rather than time.

For additional information about CRG, please contact:

Lynn S. Bachrach, President and CEO
Clinical Research Group, Inc. (CRG)