What a Vendor Owes You in Writing

Part of Clinical Project Management (PM) Training: Vendor and CRO Oversight.

About 1 minutes. Free, in your language, no account needed.

The contract is the oversight instrument

A central laboratory, an IRT provider, a courier, an imaging vendor and a CRO all do work the trial depends on. What you can require of them later is what the agreement and its specification say now.

Three things need to be explicit, and frequently are not.

Service levels with numbers. Sample results returned within how many days. System downtime tolerated per quarter. Query response within how long. A commitment to be responsive is unenforceable.

Data transfer specifications. Format, frequency, the fields, and what happens to a record that fails validation. Most external-data problems trace to a specification that was written once and never updated after a protocol amendment.

The right to audit. If you cannot inspect, you cannot oversee, and the sponsor's oversight duty does not lapse because a vendor prefers not to be audited.

Qualification is not a formality

A vendor is qualified before use, and the qualification is documented. For a system that holds trial data, that includes validation evidence. For a laboratory, accreditation and the normal ranges you will be using.

Qualifying a vendor after they have started is a finding, and a common one when a trial adds a country late and needs a local courier quickly.

Oversight after signature

Vendors drift. Staff change, volumes rise, a subcontractor appears that you did not approve. Scheduled governance meetings with minutes, reviewed performance against the service levels, and an issue log are what make oversight demonstrable.

The specific thing to watch for is subcontracting you were not told about. The obligation to oversee follows the work, not the invoice.