Investigator Notification System Implementation – Case Study


This page deals with a case study on the topic of Investigator Notification System Implementation for conducting clinical trials.

The customer is an international CRO for pharmaceutical companies. The services include the design and implementation of clinical studies, including all required processing of (serious) adverse events from clinical studies. Daily activities included manually notifying investigators about safety-related issues such as SUSARs. This manual process was resource-intensive and error-prone. There was no solution on the market that met the customer’s requirements, so a bespoke solution was necessary. In the project, which was continuously supported by QFINITY employees, the customer wanted:

  • Development of robust and compliant processes to electronically distribute safety information to investigators.
  • Enable process control through metrics and reports
  • Establishing an electronic signature for important process steps, e.g. acknowledgment of receipt of information by investigators
  • Integratation of the solution into the customer’s CTMS system
  • Validation of the system according to the risk-based approach of GAMP 5, taking into account the new processes, integrations and functionalities, in order to meet the international regulatory requirements
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Project execution

First, new data entry and distribution processes had to be developed that took into account pharmacovigilance and clinical trial compliance and customer expectations. Detailed requirements had to be drawn up from these processes in order to enable the system development with an external partner. During these phases and the subsequent implementation project, the QFINITY employees supported the following areas:

  • Supplier evaluation (audit) to evaluate the QMS of the system development partner.
  • Review and revise the new processes to ensure that they meet international regulatory requirements, including but not limited to ICH E6 R2, pharmacovigilance regulations, ER / ES regulations such as 21 CRF Part 11 and data protection regulations such as GDPR.
  • Risk assessment of the processes and the supporting system to enable a lean validation approach
  • Design of integrations to reduce processing times, reduce manual reconciliation activities and increase data integrity
  • Planning, execution and summary of the system validation including:
    • Requirements acquisition taking into account business, regulatory, data protection and IT aspects
    • Risk assessment and development of the validation strategy in cooperation with all partners
    • Validation planning including the scaling of activities based on the risk assessment
    • Installation qualification in close cooperation with the IT department of the CRO
    • Configuration review as part of operational qualification
    • Design and creation of the user acceptance test
    • Validation of the system integrations developed by the customer
    • Design and validation of reports and metrics within the CRO’s business intelligence platform

Result and benefit

The project was successfully completed and the validation activities were appropriately scaled taking into account the results of the risk assessment. The excellent communication between the customer, the external development partner and the validation team was an important success factor. It enabled a holistic validation approach from the business process to the user requirements to the development specifications. The entire approach and all activities could be designed from the development test to the user acceptance test, thus demonstrating the desired process support and the suitability of the system for the intended use.

The solution provided detailed compliance data and metrics so the company can demonstrably meet the compliance expectations of its customers and regulators.

As the solution was “the first of its kind” in the industry, the approach, system and validation documentation were thoroughly examined without any major problems being found.

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