Contacts: David W. Lown, General Manager, MCRA – (212) 583-0250 extension 2111 or dlown@mcra.com

MCRA Announces Partnership Integrating Regulatory
and Adaptive Statistical Designs in Clinical Trials

Washington, DC – April 14, 2010 – Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), the leading musculoskeletal consulting firm, today announced an exclusive co-marketing partnership with Biomedical Statistical Consulting (BSC), Wynnewood, PA, a leader in the design and implementation of creative approaches to classical (frequentist), Bayesian, and adaptive statistical design to clinical trials. 

The new partnership will enable MCRA clients to benefit from an integrated approach to clinical trial design and implementation in response to changes issuing from regulatory bodies such as FDA's Center for Devices and Radiologic Health (CDRH).   

Glenn Stiegman, Vice President of Regulatory Affairs at MCRA, said, “Medical device regulations and pathways are constantly evolving. MCRA’s clientele develop the most innovative technologies and require cost effective approaches to drive their technologies from conception to market as expeditiously as possible. We have previously worked with BSC on multiple PMA / IDE clinical trials and the combination of our skill sets will create efficiencies leading to best-of-class clinical trial execution.”

The commercialization of orthopedic device technology in the United States is taking longer and costing more due to regulatory, compliance, reimbursement, and competitive factors. The impact of this on company owners, investors and executives can be multi million dollar cost overruns without return on investment.

Today, most clinical trials utilize the classical (frequentist) based statistical approach. However, in certain circumstances clinical trial designs utilizing a Bayesian approach can increase the prospect of a successful trial.

The combined service offerings of MCRA and BSC include the strategy, development, and execution of regulatory submissions, as well as clinical trial set-up and implementation, in addition to quality assurance, reimbursement and compliance oversight.

The CDRH issued its final Guidance on the use of Bayesian statistics in clinical trials in February 2010. MCRA and BSC believe that Bayesian adaptive design as well as other approaches can lead to important efficiencies in selected contexts but that no single approach fits all situations.

Greg Maislin M.S., M.A., Principal Biostatistician of Biomedical Statistical Consulting said, “A biostatistician’s toolbox should include frequentist, Bayesian, and adaptive design approaches. BSC has specialized in applying statistical methodology in the orthopedics industry since 1986 and our partnership with MCRA will enable us to bring elegant solutions to the ever more complex problems surrounding the clinical trial and US regulatory process.”

David Lown, General Manager of MCRA, said, “MCRA’s goal is to team with the industry’s most accomplished statistical experts creating a seamless integration of services. The talent that has been assembled at MCRA is special, and with the value added by the BSC team, we will continue to help orthopedic companies of all kinds continue to bring innovative and life changing treatment options to patients.”

About MCRA, LLC
MCRA was founded in 2004 and is the leading neuro-musculoskeletal consulting firm assisting companies at all stages of development, whether they are single-product companies or companies with several thousand technologies. MCRA provides “first-in-class” service to its clients through its superior knowledge base, global surgeon relationships and deeply experienced management team. The true value of MCRA is the integration of five business value creators — regulatory, reimbursement, clinical, intellectual property and quality assurance. MCRA’s integration of these key value creating initiatives, as well as its focused specialization, creates unparalleled expertise to its clientele.  

About Biomedical Statistical Consulting
Biomedical Statistical Consulting was founded in 1986 and specializes in the design, implementation, and presentation of regulatory clinical trials with special focus on trials involving orthopedic devices. BSC collaborates with Sponsors in hypothesis and outcome measure development; statistical power and sample size analysis; and in the interpretation and presentation of statistical analysis results. BSC key services include SAStm system programming; table generation; representing Sponsors at FDA working meetings and Panel meetings; and Statistical Analysis Report (SAR) report writing for regulatory and scientific purposes.