Developing a cost-effective and efficient safety case management solution for data coordinating center projects.

Area of Science:

• Clinical Research Operations
• Pharmacovigilance
• Regulatory Compliance

Background:

• Centralized safety functions streamline serious adverse event (SAE) management across multiple clinical trials.
• Previous reliance on FDA-regulated pharmacovigilance software (21 CFR Part 11 compliant) led to inefficiencies due to system incompatibilities and high costs for low-volume SUSARs.

Purpose of the Study:

• To develop and implement a cost-effective, efficient, customized safety case management solution for data coordinating centers (DCCs).
• To demonstrate the feasibility of meeting regulatory reporting requirements without specialized pharmacovigilance software, particularly for organizations with low SUSAR volumes.

Main Methods:

• Internal analysis of existing workflows, systems, and processes within the data coordinating center.
• Development of a customized solution leveraging existing electronic data capture (EDC) and document management systems.
• Ensuring compliance with FDA regulations, including 21 CFR Part 11, without additional software expenses.

Main Results:

• A customized safety case management process was developed, mimicking key functionalities of previous software.
• The new solution was implemented in December 2022, utilizing existing infrastructure.
• The customized process ensures 21 CFR Part 11 compliance and offers a cost-effective alternative.

Conclusions:

• Customized safety case management solutions are advantageous for DCCs and academic research sites needing to meet regulatory reporting requirements.
• This approach provides a cost-effective option for organizations handling a limited number of suspected unexpected serious adverse reactions (SUSARs).
• Lessons learned from the development and implementation process offer valuable insights for similar organizations.