Compliance
Regulatory rigor, documented
Participant protection and data integrity are the foundation of every protocol we run.
Good Clinical Practice
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, and reporting trials that involve human participants. Our staff complete documented GCP training and refresh it on a defined schedule.
IRB oversight
An Institutional Review Board reviews each protocol, the informed consent document, and recruitment materials before any participant is enrolled. The IRB is an independent body whose role is to protect the rights, safety, and well-being of participants.
Data integrity and privacy
Source documentation is completed contemporaneously and retained securely. Access to participant information is limited to delegated staff, and data shared with sponsors is coded rather than identified wherever the protocol allows.
- Access-controlled physical and electronic records
- HIPAA-aligned handling of protected health information
- Documented delegation of authority and training logs
- Audit and monitoring readiness maintained throughout the study
Frequently asked questions
Answers to questions we hear most often.
What is an IRB and how does it protect participants?
An Institutional Review Board is an independent committee that reviews clinical research before it begins and monitors it while it is ongoing. Its purpose is to confirm that risks are reasonable, that consent is adequate, and that participant rights are protected.
What is GCP (Good Clinical Practice)?
GCP is an internationally recognized quality standard covering how trials are designed, conducted, recorded, and reported. It exists to protect participants and to ensure the data produced is credible.
How is HIPAA compliance maintained?
We limit access to protected health information to delegated study staff, store records securely, and obtain a specific authorization from participants describing how their information may be used and shared for the study.
Are studies here regulated by the FDA?
Trials of investigational drugs, biologics, and devices are conducted in accordance with applicable FDA regulations, including requirements for informed consent and investigator responsibilities.
Can I withdraw my consent later?
Yes. Participation is voluntary and you may withdraw at any time. The study team will explain any safety-related follow-up recommended after withdrawal.
Need our compliance documentation?
Sponsors and monitors can request site qualification materials directly.
Request informationInformation on this website is provided for general educational purposes about clinical research and is not medical advice. Participation in any study is voluntary.