The VendorVigilance Blog
Notes on vendor oversight
Practical writing on managing clinical trial vendors — oversight, compliance, and how we build VendorVigilance.
Clinical Trial Vendor Management Software: Buyer's Guide
Clinical trial vendor management software buyer's guide: evaluate tools on the inspection-ready oversight evidence they produce, not dashboards.
Clinical Trial Vendor Management Plan and SOP
The clinical trial vendor management plan and SOP do different jobs — and inspectors expect both. What each document must contain, and how the two fit together.
GCP Vendor Oversight: What the Regulations Actually Require
GCP vendor oversight, clause by clause: what ICH E6(R3), 21 CFR 312.52 and EU CTR 536/2014 require of sponsors — and what inspectors actually check.
Types of Clinical Trial Vendors: Matching Oversight
Types of clinical trial vendors, and how to match oversight to each: the vendor type sets what is at risk, so sort by potential harm, not by spend.
CRO Oversight in Clinical Trials: The Delegated Vendor
CRO oversight in clinical trials: the CRO is the one vendor you can transfer regulatory obligations to in writing. Everything else stays with you.
Vendor Performance Metrics in Clinical Trials
Vendor performance metrics in clinical trials should trigger decisions: KPIs tied to thresholds and actions, built from the data vendors touch.
Vendor Risk Assessment in Clinical Trials
Vendor risk assessment in clinical trials lets risk set oversight — judging vendors by the ICH E8 critical-to-quality factors their failure would put at risk.
Clinical Trial Vendor Audits: A Risk-Based Program
Clinical trial vendor audits are a risk-based decision, not a calendar ritual — a program, independent of monitoring, that audits where risk warrants.
Vendor Qualification in Clinical Trials: Risk-Tiered
Vendor qualification in clinical trials proves with evidence that a provider meets your standards — tiered to the risk each vendor actually carries.
Clinical Trial Vendor Selection: Capability, Not Price
Clinical trial vendor selection is the first act of oversight: choose for capability, not price, and build the evidence an inspector later reads.
Vendor Oversight in Clinical Trials: Inspection-Ready
Vendor oversight in clinical trials is a documented, risk-based system that stays with the sponsor even when the work is transferred to a CRO or vendor.
Vendor Management in Clinical Trials: Accountable Oversight
Vendor management in clinical trials keeps sponsor accountability for outsourced work — a proportionate, risk-based oversight system under ICH E6(R3).