HRP Services
General Consulting Retainers
Navigating complex and changing regulatory, policy, and accreditation requirements is increasingly difficult for most organizations to manage independently. Many clients choose to engage HRP Consulting on a retainer basis so that HRP can help as needs arise rather than contracting for each specific need, and managing with the delays associated with such. With a broad scope of work, we can help with anything from on-call support to answer reviewer or administrator questions to more complex needs such as managing regulatory changes. Retainer agreements can be set up with a set renewable block of hours or on a pay-as-you-go basis, whatever works best for your organization.
OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
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”:...