HRP Services

Compliance Assessments, Audits

 

HRP Consulting is frequently asked to assist organizations by providing an independent assessment of investigator, committee, or program compliance with regulatory or accreditation standards.  Whether routine QA or for-cause, comprehensive or targeted, or an evaluation of inspection or accreditation readiness, HRP is prepared to help.

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”:...