HRP Services
Program Evaluation
Many organizations recognize the value in having an external entity conduct a comprehensive unbiased review of their research oversight programs and committees to evaluate compliance, structure, effectiveness, efficiency, processes, accreditation readiness, staffing, or any number of factors. Program evaluations help organizations identify and understand strengths, weaknesses, and areas of potential risk, and where to best focus their attention to improve or enhance their programs.
Whatever the purpose, HRP Consulting Group can conduct a comprehensive, customized program evaluation to help you achieve your goals.
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...