At MedSource, our diverse, knowledgeable and highly trained professionals provide first-rate support to the clinical research operations of Sponsors. Our Study Startup team drives site startup activities to meet the demanding timelines for first- patient- in (FPI).  Our Clinical Records team ensures trials are set up for success from beginning to end, collecting, filing and maintaining records in strict compliance with all applicable regulations.  Examples of our core study startup and clinical records services are listed below.

Study Feasibility

  • Epidemiology analysis including targeted patient profile definitions of disease symptoms and treatment options vs standard of care
  • Competitive trial landscape
  • Enrollment projections based off of disease incidence and prevalence
  • Historic experience and recruitment rates of sites and investigators

Site Startup

  • Identification of sites through evaluation of site and investigator qualifications
  • Site start-up forecasting and timeline build
  • Central & Local IRB/IEC submissions, including protocol amendments, ICF revisions and subject-facing materials
  • Creation of study-specific site-level essential document templates
  • Collection, review and approval of essential documents for site activation
  • Negotiation, review and approval of informed consent forms (ICFs)
  • Site Clinical Trial Agreements (CTA) contract development and language negotiations
  • Site and Investigator grant / budget development and negotiations

Clinical Records Management

  • Setup and build of paper, electronic and hybrid trial master file (TMF)
  • Quality review and filing of clinical trial records within TMF
  • TMF query management and resolution