HRP Consulting prides itself on its wide network of consultants and professional associates with experience in multiple aspects of research oversight and compliance, including, but not limited to, the following:
- HIPAA Privacy Board Functions
- International/Transnational Research
- Conflicts of Interest (COI)
- Reporting to Federal Agencies
- Research Misconduct
- Compliance Assessments/Audits
- CAPA Training (e.g., Investigator Responsibilities, Subpart Determinations, etc.)
Our solutions and services are always customized to best meet the needs of our individual clients, please contact us at (347) 862-9321 or by email at firstname.lastname@example.org so that we can discuss your needs.
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...