Audit Readiness for CROs and Clinical Trial Sites
Inspection readiness for CROs and clinical trial sites.
eTMF review, sponsor audit readiness, and ICH E6 GCP and 21 CFR Part 11 checks, built into every Stage-Gate review.
Audit Readiness · CROs and Clinical Trial Sites
Audit-ready from Day 1, not the week before the inspector arrives.
Sponsor audits and regulatory inspections examine what a study did months earlier. Clinical TrialRx runs inspection-readiness reviews for CROs and clinical trial sites, so the record holds when it is opened.
For CROs
- Inspection-readiness reviews across a multi-sponsor portfolio
- eTMF review against the DIA TMF Reference Model
- Vendor and subcontractor oversight evidence
- Audit readiness built into every Stage-Gate review, through close-out
For Clinical Trial Sites
- Readiness for sponsor audits and regulatory inspections
- Regulatory binder and source documentation review
- Delegation, training, and informed consent records
- ICH E6 GCP and 21 CFR Part 11 checks on electronic systems
From the Principal's Record in Prior Roles
- Sponsor audits and inspection-readiness reviews across multi-sponsor portfolios
- Client and vendor audits, site qualification, monitoring, and close-out as a North America team leader for a global sponsor
- A global CTMS implementation across 21 international affiliates
- Four site research programs built, all global top enrollers
Find the gaps before the auditor does.
Engage Clinical TrialRx
Your trial is off-course.
Your trial is off-course.
We put it back on target.
Start with a no-obligation rescue assessment. We will diagnose where your program has drifted, map the Voice of the Client (VOC) and Seven Pains failure points actively dragging it, and show you a governed path to recovery in 30 minutes.
Headquarters
2 East Main Street
Pittsboro, IN 46167
Pittsboro, IN 46167
Remote delivery worldwide · on site when needed
Leadership
drc@clinicaltrialrx.com