Safety Management

NERI has a proven track record of organizing, managing, serving on, and performing statistical analyses for Data Monitoring Committees (DMCs), also known as Data Safety Monitoring Boards (DSMBs). This experience is the foundation of our expertise in the creation of DMCs.

Independent and unbiased DMCs are a critical part of most clinical trials. NERI offers inclusive and integrated DMC services that provide objective analyses to pharmaceutical, biotechnological, and medical device companies.

For over 30 years, we have developed a large pool of expert clinicians and scientists who could serve on your DMC.

Specific DMC Services

NERI’s Safety Team is integrated throughout a project lifecycle ensuring timely and accurate identification, evaluation, reporting, and reconciliation of safety issues in clinical trials and post-market surveillance. Our staff provides safety oversight by starting with a Safety Management Plan that describes event reporting procedures. Our specific services include:

  • AE receipt, review, and follow-up
  • AE coding using MedDRA
  • SAE/SUSAR source documentation
  • Narrative development
  • Collection of safety data
  • Preparation of information for reporting to regulatory authorities (MedWatch/CIOMS)
  • Reconciliation between Safety and Clinical databases prior to database closure