Regulatory Affairs and Study Start Up

At MedSource, our diverse, knowledgeable and highly trained professionals provide first-rate support to clinical research operations. From cancer trials to central nervous system (CNS) research, this team performs a variety of functions for our clients, maintaining strict compliance with all applicable regulations.

Services include:

  • setting up and managing trial master file (TMF)
  • creating, disseminating and collecting site-level regulatory documents during study startup
  • receiving, reviewing, filing and maintaining essential documentation
  • creating, evaluating and reviewing informed consent templates
  • customizing study-specific filing systems, regulatory document tracking tools and archive files