Case Study: Investigator Notification System.
How we helped an international CRO build a bespoke solution for notifying investigators electronically. The solution is GxP-compliant, integrated and validated using a risk-based approach per GAMP 5.
Manual, error-prone and without a solution on the market.
Notifying investigators about safety-related issues such as SUSARs by hand, day after day, was resource-intensive and error-prone. With no commercial product on the market able to meet the requirements, a bespoke solution was the only way forward. The customer set out to achieve:
- Robust, compliant processes for distributing safety information to investigators electronically
- Process control through metrics and reports
- Electronic signatures for key steps, such as investigators acknowledging receipt of the information
- Integration of the solution into the customer's CTMS
- Risk-based validation per GAMP 5 to meet international requirements
From new processes to a validated solution.
We began by designing new data-entry and distribution processes that reflected pharmacovigilance and clinical-trial regulations alongside the customer's own expectations, then translated them into detailed requirements for development with an external partner. Throughout development and rollout, QFINITY's contribution centered on:
A solution that makes compliance demonstrable.
A key success factor was the excellent communication between the customer, the external development partner and the validation team. It made an end-to-end validation approach possible, one that ran from the business process all the way through to the development specifications.
The project ran under ICH E6(R2). The solution was validated using a risk-based approach per GAMP 5. The QFINITY-co-authored ISPE GAMP eClinical Good Practice Guide (2nd edition, 2024) sets out that methodology for GCP-relevant systems. Today, ICH E6(R3) and the EMA guideline on computerised systems are the framework we work in.
First of its kind, assessed with no major deficiencies.
An industry first, the bespoke solution was thoroughly assessed and released with no major deficiencies, backed by solid compliance data for customers and regulators alike.
More from our project work.
Custom GxP systems, demonstrably validated.
You need a solution the market does not offer. We support you from process design and supplier audit through to risk-based validation per GAMP 5. In a free intro call (about 30 minutes), we map out your requirements, the right validation depth, and the integration points your project needs.
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