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REGULATORY AFFAIRS AND COMPLIANCE

Our clinical trials team has extensive experience in working with site-level and central IRBs and is committed to maintaining compliance with all applicable local and federal regulations. We oversee and support regulatory activities beginning at study start-up to ensure timely submission and approval as well as maintain a complete and comprehensive study file internally and ensure file maintenance at the site level. The activities include:

  • Trial Master File (TMF) setup and maintenance
  • Registration for and maintenance of www.clinicaltrials.gov page
  • Assist sites with preparation and management of regulatory applications and submissions
  • Central IRB management
  • Regulatory package development, distribution and collection at study start-up and throughout the trial
  •  Create and review Informed Consent Form templates