HRP Services
Customized Policies, Procedures, & Tools
HRP Consulting maintains a suite of template Standard Operating Procedures (SOPs), Forms, Checklists, and other tools and resources to support compliance with federal regulations, guidance, and accreditation standards (when desired). Customization is critically important with one of the most common findings in inspections, audits, and accreditation reviews being the failure to adhere to one’s own written policies and procedures. Using HRP’s templates as a point of reference or a base, our consultants can work with your organization to evaluate and enhance your existing materials or to develop new materials, always customized to your organization.
IND Safety Reports and IRBs
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 Announces ClinicalTrials.Gov Enforcement Action
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...