Case Study: Drug Safety Implementation


This page explains a case study on the topic of drug safety implementation.

The customer is an international CRO for pharmaceutical companies. The services include the processing of (serious) adverse reactions / events from clinical studies according to customer requirements. Daily activities range from entering adverse reaction reports, coding and data management to medical assessment and regulatory submissions that the customer performed with an outdated and customized COTS drug safety solution. Since a major upgrade was necessary anyway in order to continuously meet the regulatory requirements, e.g. for E2B reporting, the customer wanted:

  • Creation of a catalog of requirements to prepare for the market analysis
  • Evaluation of the leading drug safety solutions on the market as potential replacements for the existing solution in order to prepare an informed decision
  • Updating the existing drug safety solution or implementing a new system
  • Assess and redesign workflows to get the most out of the system and meet customer expectations
  • Integration of the drug safety solution into the customer’s IT landscape for the automated exchange of data from and to EDC or CTMS systems
  • Validation of the system using the risk-based approach based on GAMP 5, taking into account the new processes, integrations and the new functionalities to meet international regulatory requirements
QFINITY Drug safety Implementation

Project execution

In the first phase, the leading drug safety solutions on the market were checked for compliance with pharmacovigilance and clinical trial regulations and conformity to customer expectations. A new drug safety solution was selected to replace the existing solution. During the following implementation project, QFINITY employees organized the system validation. We supported the following areas in particular:

  • Supplier evaluation (audit) to assess the supplier’s QMS as well as the system functionality and controls for compliance with regulatory requirements.
  • Design of new workflows to increase efficiency as well as compliance; risk assessment of the processes and the supporting system in order to enable a lean validation approach
  • Development of integrations to reduce processing times, manual reconciliations and to 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
    • 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 of lean validation and documentation approaches for recurring changes, e.g. MedDRA updates
    • Planning and support of E2B test activities with regulatory authorities

Result and benefit

The project was completed on time and within budget as the validation activities were scaled appropriately. The test activities were well prepared and could be carried out without major problems.

As expected the implemented solution increased efficiency and compliance significantly. The improved data integrity control as well as the reduction of manual steps, such as manual data transcriptions, increase the data integrity for the entire area considerably.

Also the validation approach and the documents were checked by the internal quality assurance of the CRO after the project and no problems were identified.

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