FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

FDA Services for Clinical Studies / Trials

Over the years, clinical studies and trials for pharmaceuticals and medical devices have become more heavily regulated by the FDA.

Getting and staying in compliance with the ever-changing FDA regulations can be a challenge. Our FDA consultants can help with clinical trial design, development, and monitoring, ensuring full FDA compliance.

We offer a full range of FDA consulting services for clinical studies and trials.

Contracted Monitoring and Study Management Services

  • HIPPA compliant clinical trial operations models
  • eClinTMS (a clinical trial management system)
  • study specific monitoring plan and report development
  • regulatory document collection and tracking
  • eClinLMS (a learning management system)
  • standardized documents (including informed consents, authorization forms, source document templates)
  • investigator recruitment
  • development of SOPs for sponsors, CROs (Contract Research Organizations), and sites, in the areas of managing, monitoring, and coordinating clinical trials
  • development of study material, including a Site Study Binder with GCP Educational Action Plans
  • quality improvement consultations
  • FDA regulatory consultations

Clinical Trial Design and Development Services

  • protocols (review and write)
  • case report forms (review and design)
  • quality improvement consultations
  • FDA regulatory consultations

For more information on FDA consulting services for clinical studies and trials or to schedule a consultation, please contact us.