Associates for Research Compliance (ARC)
ARC provides consultation for investigators conducting research. The consultation aims to promote excellence by the research team, not only by ensuring compliance with federal regulations and guidance, but also by enhancing capture of data and endpoints required by a given protocol. PEER meets its objectives by conducting evaluations, monitoring, or audits of studies. If any deficiencies or findings of noncompliance are discovered, PEER conducts a methodical root-cause analysis. Appropriate corrective action plans and recommendations are then developed together with the research team for implementation.
We can enhance excellence within a research team by helping you implement a Quality System that can provide real-time checks and balances to help ensure that your research team is collecting all data and endpoints required by the protocol. A major benefit of the Quality System is to help ensure appropriate safety oversight of subjects, thereby also enhancing risk management of a portfolio of studies. Contact us to find out how implementation of a Quality System can significantly improve the conduct of your research protocols and expand your research enterprise.
PEER also provides expert guidance and preparation for FDA audits and prepares responses to FDA 483 reports or FDA warning letters. In fact, we have extensive experience responding to FDA audits.
- Implementation of a Quality System for Conduct of Research by Investigators
- Consultation on Ethical Design of Studies
- Consultation on Interactions with FDA
- Staff Training and Development
- Development of Case Report Forms (CRFs) for Investigator-Initiated Studies
- Drug or Device Accountability
- Monitoring of Studies for Sponsor-Investigators
- Preparation for FDA Audits
- Responses to FDA 483 Reports or Warning Letters