As a sponsor or CRO, your organization is already familiar with AAHRPP accreditation. And, if you are like other organizations, you are by now requiring accreditation for the independent IRBs that you work with and giving funding preference to accredited universities and hospitals. But, have you considered whether you are next in line for accreditation?
Working with accredited IRBs and institutions is not enough to protect subjects in clinical research. Sponsors and CROs also have a role in ensuring a higher standard of protection for research subjects. And, there is no better way to demonstrate your organization’s commitment to conducting ethically sound research and ensuring public trust than by achieving accreditation for your own research and development operations.
While you may think that accreditation is an institutionally-driven and IRB-centric process, accreditation is no longer just for universities and hospitals. HRP can take the guess work of interpreting the AAHRPP Standards and Elements relative to your sponsor or CRO functions. We’ve already developed industry-specific guidance for you—just ask for it.
Should you choose to pursue accreditation, we can offer the following:
- Industry-specific guidance documents for interpreting and applying the Standards.
- Readiness assessment and gap analysis to prepare for accreditation.
- AAHRPP compliant template SOPs that can be customized to your operations.li>
- Strategies for implementing procedural changes for AAHRPP compliance.
- Communication strategies with AAHRPP.
- Building your AAHRPP application and response packages.
- Assistance in responding to AAHRPP Step One Reports, Draft Site Visit Reports, Improvement Plans, and Status Reports.
HRP Consulting Group has helped approximately 25 organizations earn the AAHRPP seal and is in the process of working with a number of others. We will help your organization achieve accreditation while maintaining established industry norms in the process. Our staff will collaborate with our partnering associate, Lindsay McNair, MD, MPH; Dr. McNair is a medical consultant to the biopharm industry on drug development and clinical research, and is the founder and principal of Equipoise Consulting.
For more information about our accreditation support services, please contact us at (347) 862-9321 or by email at services@thehrpconsultinggroup.com.