VendorVigilance - Clinical Trial Vendor Management
Vendor Management System for Pharma and Biotech

Pass vendor inspections with confidence, not last-minute preparation

VendorVigilance delivers systematic, demonstrable oversight of every vendor from selection through study close-out. Inspection-ready by design.

21 CFR Part 11 Compliant
ICH E6(R3) Aligned
GxP Validated

Vendor oversight wasn't designed for how pharma works

Fragmented processes

Selection criteria rebuilt for every procurement. Qualification templates that differ between studies, between team members, between quarters. Risk assessments with no common framework.

The quality of oversight depends on who is doing it, not the system they work in.

Invisible data

Qualification dates, contract terms, risk scores, performance observations: the information exists, but it lives in spreadsheets, shared drives, and email threads. No function has a complete, current view.

Decisions are made on partial information. Trends stay invisible until they become incidents.

Siloed communication

QA completes a qualification without notifying the study team. A risk is raised without reaching the team deploying that vendor. A contract renewal is processed without informing the qualification owner.

Critical information travels through informal channels that break down under pressure.

These three failures create exactly the conditions regulatory inspections are designed to find.

Start with what you need

VendorVigilance is modular. Enable the capabilities your organisation requires today and expand as your programme matures.

Vendors

Central registry of all vendors, services, subcontractors, and studies. Every vendor in one place with an aggregate risk score.

Selections

Structured evaluation workflows from direct awards to competitive RFPs with template-driven scoring and analysis.

Qualifications

Template-based qualification processes with automatic expiry tracking. On-site, remote, or desktop configured to your standards.

Governance

Contracts, deliverables, KPIs, and meetings. Track obligations, measure performance, and flag expiries before they lapse.

RIM

Six risk types purpose-built for clinical vendor oversight: emerging risks, quality issues, audit findings, TOROs, CTQFs, and baseline risks.

Requests

Structured questionnaires sent to vendors with response tracking. Draft, send, collect, and review all in one workflow.

Tasks

General-purpose work items linked to any object in the system. Track activities across your entire vendor portfolio.

Reports

Fifteen built-in reports across selections, qualifications, deliverables, KPIs, risks, and more. Bar chart visualisation, filtering, and image export.

Core platform: Dashboard, audit trail, notifications, role-based access control, and global study filter included with every deployment.

VendorVigilance Modular Architecture - Vendor Registry Central Hub

Five functions, one platform

Quality Assurance

"We need to prove our oversight programme works — not reconstruct it before every inspection."

Run qualification programmes, track audit findings and CAPAs, and maintain inspection-ready documentation across your entire vendor portfolio. VendorVigilance replaces the manual assembly of evidence with a continuous, auditable record.

Quality Assurance use case →
Quality Assurance vendor oversight dashboard
Clinical Operations vendor management dashboard

Clinical Operations

"We can't wait for QA to tell us a vendor qualification has expired. We need to see it ourselves."

Monitor vendor performance against study timelines, track deliverables, and ensure the vendor lifecycle stays synchronised with your clinical programme. The global study filter puts everything in context instantly.

Clinical Operations use case →

R&D Sourcing

"Every selection runs differently because there's no standard process to follow."

Manage vendor evaluations from requirements through award with template-driven selection workflows and standardised scoring. Access existing qualification status, performance history, and risk context from the vendor registry so selection decisions are informed by the organisation's full vendor intelligence.

R&D Sourcing vendor selection and scoring dashboard
Vendor Alliance Management consolidated vendor ecosystem dashboard

Vendor Alliance Management

"The information exists — it's just in four different systems and none of them talk to each other."

See the full vendor ecosystem in one place: qualification status, contract coverage, open risks, and performance data without assembling it from disconnected spreadsheets and shared drives. VendorVigilance gives Vendor Alliance Management the consolidated, current view they need to hold the strategic oversight layer together.

Executive Leadership

"I need a portfolio-level view of vendor risk without commissioning a report every time."

Real-time visibility into vendor risk scores, qualification status, contract coverage, and programme health on demand, not on request. Fifteen built-in reports with one click.

Executive Leadership use case →
Executive Leadership vendor risk and portfolio dashboard

Built differently, on purpose

Purpose-built for clinical vendor oversight.

Not a procurement tool adapted for pharma. Not a QMS with a vendor module bolted on. VendorVigilance was designed from day one for GxP clinical trial vendor management — and nothing else.

Compliance is architecture, not a feature.

21 CFR Part 11-compliant audit trail. Role-based access control scoped by study, module, and object type. ICH E6(R3)-aligned risk management. Compliance isn't added on top. It's how the platform works.

Configured, not coded.

Template libraries for qualifications, selections, risk assessments, KPIs, meetings, and vendor types — all customisable through the application interface. No scripting, no development tools, no IT dependency.

Study context connects everything.

A global study filter links every vendor management activity to the clinical programme it serves. Qualifications, contracts, risks, and deliverables — all visible through the lens of the study. Two lifecycles, finally synchronised.

Before and After - Unified Vendor Management Platform