HRP Services
Training & Education
HRP consultants and our network of research professionals have extensive hands on experience with both the oversight and conduct of research in a wide variety of settings including academia, health care, government agencies, foundations, independent IRBs, and more. HRP can leverage its experience to support your internal training needs, including initial and ongoing training of leaders and staff with key responsibilities for research, committee chairs and members, and investigators and their staff. HRP will work with you to identify the best solution for your education and training needs, on-site or remote, comprehensive or topic-based, from 15-minute topic sessions during committee meetings to full day programs.
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...