How to Qualify a Central Laboratory for a Multi-Region Trial
Assess a laboratory against the trial you are running, not against its brochure.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
A central laboratory promises comparability: the same method, the same instrument platform, the same reference ranges across every region a trial runs in. Qualification is the process of establishing that the promise holds for your assays, your matrices and your logistics. Sponsors who qualify the organisation rather than the specific service discover the gap when samples from one region behave differently from the rest.
- 1
Define what you are qualifying it for
List the assays, matrices, volumes, turnaround times and regions. A laboratory excellent at routine chemistry may have no experience of your biomarker, and a qualification that names the company rather than the service has not asked the question that matters.
- 2
Verify accreditation scope rather than the certificate
Accreditation is granted per method and per matrix, so the schedule is the document that matters and the certificate on the wall is not. Ask which of your assays appear on it, and treat any that do not as unaccredited work you are choosing to accept.
- 3
Establish comparability across every site that will analyse samples
Where a central laboratory operates regional facilities, confirm the method, calibration, reference ranges and reporting units are genuinely harmonised, with cross-site comparison data. Unit differences between regions are a classic source of results that look like a treatment effect.
- 4
Test the logistics before the trial, not during it
Courier routes, customs and import permits for biological material, transit times and temperature performance to the regions you will actually ship from. Sample logistics fail at borders far more often than at benches.
- 5
Agree data transfer, format and reconciliation in writing
Specify the transfer specification, frequency, and how laboratory data reconciles against the trial database. Reconciliation left until database lock finds discrepancies at the point where fixing them is most expensive and least possible.
- 6
Define escalation, and audit before you commit
Agree who is contacted for an excursion, a lost shipment or a failed run, with a response time. Audit the laboratory against the scope you defined, and re-audit through the trial rather than treating qualification as a one-time event.
- !The organisation qualified rather than the specific assays and matrices the trial needs.
- !An accreditation certificate accepted without reading the schedule that says what it covers.
- !Regional facilities assumed to be harmonised, so unit or calibration differences read as treatment effects.
- !Data reconciliation deferred to database lock, when discrepancies are least fixable.
How to Qualify a Central Laboratory for a Multi-Region Trial: frequently asked questions
Common questions on qualify a central laboratory for a multi-region trial.
Is an accredited laboratory automatically qualified?
No. Accreditation is granted per method and per matrix, so the schedule tells you what is actually covered and the certificate does not. Your assay may or may not appear on it, and accreditation says nothing about turnaround, logistics to your regions, or data transfer — all of which your trial depends on.
What is the risk with regional facilities?
That they are not as harmonised as the single-provider arrangement implies. Different calibrators, reference ranges or reporting units between regions produce systematic differences that can look exactly like a treatment effect. Cross-site comparison data before the trial is what rules that out.
How often should the laboratory be re-audited?
On a risk basis through the trial, not once at qualification. Methods change, staff change, and a facility that qualified two years ago may have moved a platform since. The audit that matters is the one covering the period your samples were analysed in.