HRP Services
Accreditation Assistance
With experience and insight in bridging the gap between existing program structure and accreditation standards, HRP Consulting Group has always been viewed as a leader in helping organizations achieve and maintain accreditation. We’ve worked with organizations large and small; from pharmaceutical companies to independent IRB’s, CRO’s, universities/colleges, academic medical centers, hospitals, non-profits and government agencies such as NIH.
Accreditation services include all or any combination of the following:
- Evaluation of your program and gap analysis.
- Assistance with interpretation and application of accreditation standards and elements.
- Development of customized SOP’s, forms, checklists and other supporting documents.
- Building your application and response packages.
- Responding to feedback provided by the accrediting organization.
- Site Visit preparation.
We realize that accreditation is a big decision, so we are happy to answer any questions that you might about the accreditation process.
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...