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.
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...