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How we helped an international CRO replace an outdated drug safety solution, from market analysis and system selection to risk-based validation under GAMP 5.
An outdated solution, growing requirements.
The client processed (serious) adverse events from clinical trials on an outdated COTS solution, from initial entry through coding and data management to medical assessment and regulatory submission. 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 around client expectations so the new solution plays to its full capability
- 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
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. A new solution was then selected as the replacement. During the implementation project that followed, QFINITY ran the system validation and, in particular, supported:
On time, on budget, no deficiencies.
With the validation activities scaled appropriately and the testing well prepared, the project came in on time and on budget, without major problems.
The solution followed risk-based validation to GAMP 5. The QFINITY-co-authored ISPE GAMP eClinical Good Practice Guide (2nd edition, 2024) sets out that methodology for GCP-relevant systems. We frame pharmacovigilance systems for clinical trials within ICH E6(R3) and the EMA guideline on computerised systems.
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 deficiencies from the internal QA.
More from our project work.
Select your drug safety system and validate it inspection-ready.
In a free initial consultation, we review your starting point, from system selection and supplier audit to 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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