Research Auditing & Monitoring
“Our team of experts can fill the research auditing and monitoring gaps needed for high quality study compliance and oversight”
Michael Belotto, PhD, CCRC, CCRA, Sr. Director, Research Education
Preparing study files for FDA visits can be challenging, especially if you don’t have the right resources. Our experienced team offers a cost-effective solution.
Our team members have a deep understanding of FDA regulations, ICH standards, and OHRP guidelines. We can offer your staff methods for mitigating risks and ensuring compliance with relevant laws, regulations, and internal policies.
Ensuring Human Subject Protection & Regulatory Compliance
We offer expertise in human subjects protection and regulatory compliance including:
• Title 45 CFR Part 46, Protection of Human Subjects
• Title 21 CFR Part 50, Protection of Human Subjects
• Part 56 – Institutional Review Boards
• Part 312 Investigational New Drugs, Part 812 – Investigational Device Exemptions
• Title 49 – Transportation of Infectious Substances
• AAHRPP Standards
High Quality Study Monitoring
Our team carefully inventories and reviews all documents including protocols, amendments, investigators’ CVs, IRB correspondence, investigator drug brochures, informed consents, financial disclosures, IND safety reports, serious adverse event reports, and Delegation of Authority forms. We also verify that:
• Investigators follow the current IRB approved protocol
• All study subjects have documented informed consents on file and in the medical record
• Subjects enrolled met eligibility criteria
• Source documents are accurate and complete
• Unanticipated problems involving risks to subjects or others are appropriately reported
Investigational Product Accountability
Our professional monitors evaluate everything from shipping and transportation procedures to handling, storage, and managing inventory of the investigational product. They also work to ensure the entire process is documented.
Coaching & Mentoring
The coaching and mentoring philosophy inherent in our approach to research compliance creates an educational experience for all involved. This enables your team to gain new knowledge and skills, which strengthens the research skills at your institution.