Clinical Drug Safety: Process & System Implementation – Case Study

Written by Marc Portner

Executive Summary

Innovative Development has a strong history of supporting clients in the Pharmaceutical industry.   Our client, a Clinical Research Organization, was having challenges with their Drug Safety processes and systems.  The Innovative Development team was able to assist the client with the deployment of new, integrated processes and systems.   Some highlights include:

• Integrated processes and systems
• Improved data accuracy and data security
• Increase in operational efficiency while maintaining current staffing levels
• Increase in Pharmacovigilance compliance.

Challenges

Our client, a Clinical Research Organization (CRO), was having difficulty with the triage, processing, and management of Adverse Events (AE) related to Clinical Trials.   Pharmacovigilance or Drug Safety departments have an important responsibility to manage the AE information as it occurs.  At our client, there were several challenges that needed to be addressed:

• The triage of AEs, as they were reported, was slow and unstructured
• The tracking of AE remediation steps was disconnected from the triage process
• The system utilized for triaging the AEs was not integrated to the system that stored the AEs
• There was a lack of process integration that created a manual work steps to be completed for each AE
• The creation of Individual Case Safety Reports (ICSR) involved several manual steps to gather data due to the lack of process and system integration.

How Professional Services Helped

Innovative Development provided resources that had Pharmaceutical / Clinical industry expertise.  The team delivered Project Management, Change Management, and Process Development to help deliver an integrated solution for the client.   By developing integrated processes, the lifecycle of an AE was trackable from triage to final reporting.  The systems and processes that were deployed allowed users to access an AE using one interface.  The results of the solution included:

• Reduction of time in triaging an AE
• Reduction in time in the management of the AE
• More accurate and more timely creation of AE / ICSR reporting
• Improved data integrity, data privacy and data security
• Ability to handle more clinical trial volume while maintaining current staffing levels
• Improved support of each clinical trial.

Results

Through the services that Innovative Development delivered, the client was able to solve the challenges that their Drug Safety team faced.  We were able to assist the client with the development of new processes, create adoption of those process in the organization, and assist with the deployment of the new systems.  The combined solution of process improvement and system integration helped our client to achieve an industry leading level of Pharmacovigilance compliance.