FDA & Monitoring Support
FDA Support
Fee-for-service professionals who are well versed in regulatory affairs (medical affairs) as it relates to drug product, medical devices, biologic products, and combination products regulated by the U.S. Food and Drug Administration (FDA). The coordinators specialize in advancing research from non-clinical animal or pre-clinical phases into clinical trials by identifying a regulatory strategy, collaborating with study teams and investigators, and preparation of the appropriate regulatory submissions.
- Regulatory affairs consultations
- Device Risk Determinations, IND Exemption Requests, Designation Requests
- Clinical, non-clinical, and pre-clinical gap analysis
- Regulatory strategy creation, implementation, and maintenance
- Original IND/IDE Applications
- Pre-IND and device Pre-submissions
- Requests and conducts meetings with FDA
- Regulatory reporting (annual, safety, final reports)
- Expanded Access protocols/IND submissions
- FDA liaisons, Authorized Representatives, Correspondents
- Clinical research monitoring
- ClinicalTrials.gov Registration and Maintenance
Monitoring Services
Fee-for-service staff available to local investigators to provide monitoring oversight to ensure subject safety, protocol compliance, and data integrity. Expertise in local and federal regulations, reporting guidelines, hospital policies, and good clinical practice.
- Oversee progress of the trial and ensure compliance through routine monitoring of regulatory documents, site files, and subject files.
- Provide support and assistance to all study sites and staff during the conduct of the study.
- Ensure all data is accurate and supported by source documentation.
- Assist with protocol-specific training (SIV, protocol amendments, etc.)
- Conduct remote and on-site review of electronic data and source data verification.
- Provide oversight to ensure subject safety and efficiency.
- Continuous monitoring of all study-related activities to ensure compliance with study protocol, institutional regulations, all applicable Federal regulations, and GCP.
- Identify and follow-up on data discrepancies and compliance issues.
- Develop root-cause analysis and CAPAs related to protocol deviations and other non-compliances.
- Ensure facilities and resources being used are adequate for conducting the trial, and that accurate records of equipment used are maintained throughout the study.
- Work with Investigational Pharmacy and study staff, as applicable, to ensure proper storage, dispensing, transportation, subject-level drug accountability, and return of investigational products are maintained and recorded appropriately.
- Prepare and distribute reports on trial status and progression.