FDA Clinical Studies & Clinical Trial Consulting Services
Over the years, clinical studies and trials for pharmaceuticals and medical devices have become increasingly regulated by the FDA under FDA GCP regulations.
Getting and staying in compliance with the ever-changing FDA regulations can be a challenge. Our FDA clinical trial consultants can help with clinical trial design, development, and monitoring, to ensure full FDA compliance.
We offer a full range of FDA consulting services for clinical studies and trials.
Contracted Monitoring and Study Management Services
We provide HIPAA compliant clinical trial operations and comprehensive study management services, including:
- 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 aligned with ICH E6(R3) GCP guidance
- Quality improvement consultations
- FDA regulatory consultations
Clinical Trial Design and Development Services
- IRB records and documents
- 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 with FDA Compliance Group, please contact us at 303-903-4801.