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Case Study: Drug Safety Implementation.

How we helped an international CRO replace an outdated drug safety solution - from market analysis and system selection to risk-based validation under GAMP 5.

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The challenge

An outdated solution, growing requirements.

The client processed (serious) adverse events from clinical trials - from initial entry through coding and data management to medical assessment and regulatory submission - on an outdated COTS solution. With a major upgrade needed in any case to keep meeting regulatory requirements such as E2B reporting, the client set out to:

Create a requirements catalog as the basis for the market analysis
Evaluate the leading drug safety solutions on the market as potential replacements
Update the existing solution or implement a new system
Redesign workflows so the new solution plays to its full capability - aligned with client expectations
Integrate the solution into the IT landscape (data exchange with EDC / CTMS)
Validate the system using a risk-based approach under GAMP 5 to meet international requirements

Project execution

Selection and validation - supported end to end.

We began by assessing the leading drug safety solutions on the market against pharmacovigilance and clinical trial compliance requirements - and against the client's expectations - and selected a new solution as the replacement. During the implementation project that followed, QFINITY ran the system validation and, in particular, supported:

Supplier evaluation (audit) of the QMS, system functionality and controls

Design of new workflows plus a risk assessment for a lean validation approach

Development of integrations - shorter processing times, stronger data integrity

System validation: IQ, configuration review (OQ), user acceptance testing (UAT)

Lean validation approaches for recurring changes such as MedDRA updates

Planning and support of E2B testing with the regulatory authorities

Results & benefits

On time, on budget - no findings.

With the validation activities scaled appropriately and the testing well prepared, the project came in on time and on budget - without major problems.

Completed on time and within the planned budget

Efficiency increased, compliance evidence simplified

Data integrity markedly improved thanks to fewer manual steps

The CRO's internal QA reviewed the approach and documents - no findings

Framing today.

The solution followed risk-based validation to GAMP 5 - the methodology that the QFINITY-co-authored ISPE GAMP eClinical Good Practice Guide (2nd edition, 2024) sets out for GCP-relevant systems. We frame pharmacovigilance systems from clinical trials within ICH E6(R3) and the EMA guideline on computerised systems.

Outcome

Efficiency and compliance - not a trade-off.

The new drug safety solution went live on time and on budget - with greater efficiency, stronger data integrity and no findings from the internal QA.

GAMP 5 Pharmacovigilance Data Integrity Audit-ready

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Select your drug safety system and validate it inspection-ready.

In a free initial consultation, we review your starting point - system selection, supplier audit or risk-based validation under GAMP 5 - and map out a lean, audit-ready path to go-live. Takes about 30 minutes.

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