Contract research organization (CRO) Prometrika and medical research consulting firm Boston Biotech Clinical Research (BBCR) are teaming up to provide data monitoring committee (DMC) services to clinical trial sponsors. Together, the companies will help sponsors establish and operate independent DMCs (also called data safety monitoring boards and data and safety monitoring committees).
Sometimes required by the FDA, DMCs help protect the safety of patients and the validity of clinical trial results by providing independent review of safety and efficacy data collected during clinical research.
Prometrika and BBCR will help sponsors recruit DMC participants, develop DMC charters and analysis plans, prepare reports and coordinate DMC meetings. The companies will also offer independent statistical analysis of data and safety monitoring.
“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, Ph.D., president and CEO of Prometrika.