Associates for Research Compliance (ARC)
ARC provides consultation for investigators conducting research. 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.
PEER also provides expert guidance and preparation for FDA audits and prepares responses to FDA 483 reports or FDA warning letters.
Services include:
- 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
