Expertise
Clinical Quality, GCP & BIMO
Clinical data supports the application. We help sponsors, investigator sites and research organizations build clinical quality systems that produce reliable, verifiable data and hold up to bioresearch monitoring review.
Clinical quality and GCP support
- Clinical quality management system design and SOP architecture
- GCP compliance assessments for sponsors, sites and vendors
- Investigator site audits and study-specific quality reviews
- Trial master file completeness and inspection-readiness review
- Monitoring oversight, vendor qualification and CRO governance
- BIMO preparation for sponsors, monitors and clinical sites
- Clinical data integrity, source documentation and eSource practices
- Protocol deviation management and clinical CAPA
Experience on both sides of the study
Our founder conducted GCP inspections as an FDA investigator, and our clinical consultants have worked within sponsor and site organizations. That combination means findings are described in terms of the actual risk to subject safety and data reliability, with corrections that fit how studies are run.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.