Use case: Clinical Operations

Your study depends on vendors you don't directly manage

You're accountable for study timelines, but qualification status, contract readiness, and vendor performance are in someone else's hands. VendorVigilance gives you real-time visibility without chasing other functions.

The problem

The challenge

Accountability without visibility

ClinOps runs the study. But the vendors that make the study possible are managed across QA, Vendor Alliance Management, and procurement, each in their own system, on their own timeline.

You have to ask for status.

Is the vendor qualified? Is the contract live? Has the change order been approved? The information exists in QA's records, in Vendor Alliance Management's tracker, in procurement's inbox, but none of it is accessible without asking. You piece together the status of your study's vendors from conversations and emails.

Notifications are either absent or noise.

Either nothing is communicated proactively, or everything is communicated to everyone without filtering for relevance. You need alerts scoped to your study: changes that actually require your attention.

Upstream delays become your problem.

A vendor cannot be deployed until they're qualified. A vendor cannot deliver until the SOW is executed. When those upstream processes slip, it's Clinical Operations that explains the study delay. But you had no visibility into the slippage until it was too late.

Your contributions disappear into email.

Quality issues you observe in vendor delivery, risks you identify during the study, scope changes that need documenting — these are raised through informal channels and rarely make it into the formal oversight record.

The solution

How VendorVigilance helps

  1. Study-scoped visibility

    The global study filter narrows every view in VendorVigilance to your study. Vendors, qualifications, contracts, risks, deliverables: all scoped to the programme you're responsible for. You see what affects your study and nothing else.

  2. Real-time status without asking

    Qualification status is visible in real time. Contract status is visible. Risk items, deliverables, KPIs: all current, all associated with your study. When QA completes a qualification, you see it. When a contract approaches expiry, you see that too.

  3. Scoped notifications

    You're notified when something changes that affects your study: a qualification status change, a CAPA due date approaching, a contract expiring. Alerts are filtered to your programme and delivered when they matter.

  4. TORO and CTQF

    Study-level risk structures that ClinOps owns directly. Record which obligations have been transferred to vendors and which the sponsor retains. Identify and monitor the factors critical to study quality. Both are associated with the vendor and the study, and sit alongside the rest of the risk picture.

  5. Structured contributions

    When you observe a quality issue in vendor delivery, raise it directly in VendorVigilance: graded, described, and assigned. It enters the formal oversight record immediately, visible to QA and Vendor Alliance Management. Risks identified during the study go into Risks & Issues, where they're visible to every function with a stake. Tasks are tracked with an owner and a due date.

  6. Vendor selection (smaller organisations)

    Where ClinOps carries the selection function, template-driven selection workflows and analysis templates provide the structure that makes vendor evaluation consistent, documented, and defensible from requirements through scoring to award.

The outcome

What you gain

Visibility, early warning, and a defensible record

See the full picture for your study.

Every vendor, their qualification status, their contracts, the open risk items: all in one place, scoped to your programme.

Get early warning.

Qualification renewals, contract expirations, CAPA deadlines: all surface as notifications before they become blockers.

Make your contributions count.

Quality issues, risks, scope changes, and escalations are recorded in the oversight record: attributed, timestamped, and traceable.

When something goes wrong, the record of what was flagged and when is there.

Stop holding it together by hand.

Good vendor oversight comes from the process, so it no longer depends on one person's effort.

See VendorVigilance in action

A one-hour walkthrough of how your vendors, studies and qualifications would look in VendorVigilance.

Explore the product

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