Improve Adverse Event Processing

Client

 A $35B global company that creates, discovers, develops, manufactures, and markets pharmaceutical products, including vaccines, over-the-counter medicines, and health-related consumer products worldwide.

Project Goals

The company desired to improve the efficiency and effectiveness of adverse event data entry functions around the world. Specifically:

• Develop and implement a “front-end” to the company’s custom adverse event system that would gather adverse event information, feed the existing system, and track processing
• Develop and implement new electronic forms that would electronically gather, validate, and transfer adverse event information into the company’s systems

Deliverables

The required systems were successfully developed and implemented in a period of two months using “shareware” developed by TCA.

Results

Efficiency surrounding adverse event processing was improved and the company was able to avoid any FDA audit findings around reporting timing requirements.