Whether you’re short staffed, just starting up an IRB, or need to supplement the expertise of your current staff or IRB, HRP Consulting Group can assist you with daily operations utilizing our expert staff and robust network of associates. We offer quick, common sense, and effective solutions, such as:
- Providing IRB staff support using our network of experienced IRB professionals, from front line staff to higher level management, both on and off-site.
- Providing temporary IRB Chairs, members or consulting reviewers.
- Providing training and mentoring to support your IRB members or staff while they gain knowledge and experience.
Our professionals have extensive hands-on experience with both social behavioral and biomedical research and have worked with most commercially available IRB software platforms.
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...