A structured, independent assessment of your site's readiness to host sponsored clinical trials. We review your staffing, SOPs, source document templates, regulatory files, and workflow capacity — and deliver a frank, actionable report that sponsors trust.
Sponsors and CROs reject sites not because of patient volume — but because of operational gaps that are entirely fixable with the right preparation.
The audit is conducted remotely. You share documents via a secure portal; we review, score, and comment. No site visit required unless you request one.
We send you a secure document request checklist covering all six audit domains. You upload documents to our encrypted portal — SOPs, regulatory binder items, source document templates, lab certifications, staff CVs, and training records. No physical visit is required at this stage.
Our experienced clinical research associates — with direct oncology trial experience at Phase I–III level — review every document against GCP ICH E6(R3) requirements, FDA guidance, and common sponsor qualification criteria. Each domain is scored and annotated with specific findings.
You receive a formal written audit report — structured exactly as a sponsor's pre-qualification report — with a domain-by-domain scorecard, specific findings, and a prioritised corrective action plan. We then hold a 60-minute debrief call to walk through findings and answer questions.
Executive Summary (2 pages)Overall readiness rating, headline findings, and top three priority actions — formatted for your site leadership and medical director.
Domain ScorecardSix-domain scoring matrix with RAG (Red/Amber/Green) status for each area, comparable to a sponsor's internal site qualification framework.
Detailed Findings AnnexLine-by-line findings for each reviewed document, citing the specific GCP requirement or sponsor expectation not met, with recommended corrective wording.
Corrective Action Plan TemplatePre-formatted table with each finding, responsible owner field, target date field, and status — ready for your QA tracking system.
SOP Gap TemplatesFor any SOP identified as missing or inadequate, we provide a compliant starter template as a Word document for your team to complete.
60-Minute Debrief CallRecorded video call with the lead CRA reviewer — transcript provided. Your PI, coordinator, and research manager may all attend.
KCLG's audit team draws on direct experience across Phase I–III oncology trials — monitoring visits, regulatory inspections, and site qualification assessments at both academic and community sites.
Pricing is fixed-fee, quoted on scope — based on your site's size, number of staff members to be reviewed, and volume of existing SOPs and regulatory documents submitted. Typical scopes are quoted within two business days of your initial enquiry.