December 17, 2009

Service establishes a new turnkey DMC option delivering independent medical and statistical expertise in safety and efficacy data monitoring for clinical research.

CAMBRIDGE, MASS.  (December 14, 2009) -- PROMETRIKA, LLC, a contract clinical research organization serving the biopharmaceutical industry, in collaboration with Boston Biotech Clinical Research (BBCR), a medical research consulting firm serving early-stage biotechnology companies, today announced that they will offer a comprehensive Data Monitoring Committee (DMC) service to the biopharmaceutical industry.  The new service is designed to support sponsors of clinical trials with a full range of expertise in the establishment and operation of independent DMCs, which are now frequently established to protect the safety of patients and the validity of results in clinical trials. 

In this collaboration, DMC services available from PROMETRIKA and BBCR include recruitment of multidisciplinary panels of key opinion leaders, development of DMC charters and analysis plans, participation of a medical specialist in drug safety and risk management to serve as DMC chairperson or member, independent statistical analysis of interim safety and efficacy data, comprehensive safety monitoring, preparation of DMC reports, and coordination and documentation of DMC meetings. PROMETRIKA and BBCR will also be positioned to serve as liaison between trial sponsors, DMCs and regulatory agencies, supporting the optimal levels of independence for sponsors.

"While PROMETRIKA has served as the data analysis center for a number of DMCs during the past seven years, our new DMC service is uniquely positioned to deliver the levels of precision, flexibility and independence that biopharmaceutical companies need to support the full range of requirements for safety monitoring and interim data analysis in clinical research," said Miganush Stepanians, PhD, president and CEO of PROMETRIKA. "Clients will get the unbiased statistical analyses and reporting they need while remaining blinded to study results."

Participants in DMCs, also referred to as Data Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs), provide independent analysis and review of safety and efficacy data generated during clinical research.  Depending on the patient population to be studied, DMCs may be required by the FDA, but increasingly they are established voluntarily by clinical trial sponsors.

Candida Fratazzi, MD, president of BBCR, said,  "While the FDA often does not require sponsors to engage external DMCs to monitor clinical research, biopharmaceutical companies are increasingly opting to establish independent DMCs because of the growing number of clinical studies that include safety and efficacy interim analyses and because they want to achieve the highest possible levels of trial integrity. Through PROMETRIKA's and BBCR's combined experience and global network of key opinion leaders, we can identify the best independent experts and provide comprehensive, high-quality DMC services to clients."



Founded in 2003 in Cambridge, Mass., PROMETRIKA, LLC, is a contract research organization that offers a full range of integrated clinical research services to its pharmaceutical and biotechnology clients, including clinical trial management, clinical monitoring, data management, biostatistics, medical writing and regulatory submissions. PROMETRIKA's team has extensive expertise and experience in managing clinical trials, analyzing and interpreting medical data, and preparing new drug applications for US and European regulatory agencies in a broad range of therapeutic areas, including cardiovascular disease, dermatology, gastrointestinal disease, inflammatory and metabolic disorders, oncology and respiratory disease. Collectively, the PROMETRIKA team has managed more than 200 clinical trials, ranging from Phase 1 pharmacokinetic crossover trials to Phase 4 long-term multi-center studies.

Additional information about PROMETRIKA products and services is available at or by contacting Chris Gallant at (617) 868-2020 x223.

About BBCR

BBCR, LLC, was founded in Cambridge, Mass., by Candida Fratazzi, MD, to address the need for innovation in clinical development among early stage biotechnology companies that do not have the infrastructure in place to plan and execute clinical development programs independently. BBCR provides expertise in the customization of clinical strategies and study design that are essential elements of success in drug and medical device development.  BBCR's services include recruitment of domestic and international key opinion leader panels, technology assessment, drug safety and risk management, clinical strategy and protocol development, and medical services related to regulatory submission, in a broad range of therapeutic areas including rare disease, genetic disease, blood transfusion, transplant, inflammatory/autoimmune disease, viral/ bacterial disease, gastrointestinal disease, endocrinology, diabetes, and respiratory disease.

Additional information about BBCR products and services is available at or by contacting BBCR at (617) 599-2602.




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