Independent Data Monitoring
Committee Services

“The need for superior quality independent DMC services has grown exponentially in recent years. Our new DMC service brings together the full range of unbiased statistical and medical expertise clients need.”

- Miganush Stepanians, PhD
President & CEO
PROMETRIKA, LLC

Independent Data Monitoring Committee (DMC) services are now an essential component of many clinical research programs. To address this rapidly expanding need, PROMETRIKA, in collaboration with Boston Biotech Clinical Research (BBCR), provides comprehensive independent DMC/DSMB/DSMC services to the biopharmaceutical industry. Our service is designed for biopharmaceutical companies that conduct their own clinical trials or that use a CRO. Throughout our history, clients have engaged PROMETRIKA to execute essential statistical analyses as participants in DMC boards. Today our DMC service brings together the full range of professional expertise sponsors need, all provided with the highest levels of independence and flexibility to produce the unbiased expert reporting that today’s clinical research programs demand. Our team provides all of the support necessary to manage the operations of a DMC successfully, including charter development, independent statistical analysis of interim safety and efficacy data, comprehensive safety monitoring, preparation of DMC reports, and coordination and documentation of DMC meetings.

With many years of experience in monitoring and statistical analysis of patient safety data, our statisticians and medical experts are readily able to recruit and engage the highest caliber external members to participate in DMCs for our clients.

We provide a seamless turnkey solution with all of the support necessary to manage the operations of a DMC successfully, including:

  • The ability to establish outstanding DMC boards from a global network of key opinion leader contacts in all relevant clinical specialties.
  • Proven expertise in all aspects of development of DMC charters and statistical analysis plans.
  • Hands-on participation of experienced medical specialists in drug safety and risk management. Data analysis and preparation of DSMB reports, including safety analyses and interim efficacy results, conducted by an independent statistics/programming team. The availability of two separate independent statistical teams positions us to address any potential conflicts of interest effectively.
  • Presentation of analysis results by Ph.D. statisticians, as voting or non-voting members.
  • All necessary clinical operations support to coordinate and execute DSMB meetings, including recording and maintaining meeting minutes of open and closed sessions.

Our depth of experience in clinical research also means that we are able to provide the related DMC support services our clients may need, including data management, data entry and administrative support.