HRP Services
Customized Policies, Procedures, & Tools
HRP Consulting maintains a suite of template Standard Operating Procedures (SOPs), Forms, Checklists, and other tools and resources to support compliance with federal regulations, guidance, and accreditation standards (when desired). Customization is critically important with one of the most common findings in inspections, audits, and accreditation reviews being the failure to adhere to one’s own written policies and procedures. Using HRP’s templates as a point of reference or a base, our consultants can work with your organization to evaluate and enhance your existing materials or to develop new materials, always customized to your organization.
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...
Institutional Review Board: Management and Function
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...