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Non-Profit Organization - OpenText Cloud-Delivered ECM

Clinical Trial Information is Current, Protected, and Governed within FDA Regulations with OpenText Cloud-Delivered ECM

Non-Profit Organization - OpenText Cloud-Delivered ECM logo

The Coordinating Center for a nationwide network of clinical research centers streamlines information management with secure access for increased efficiency and reduced risk.

We had an audit by the sponsor for one of our studies. They wanted to ensure that our content repository securely manages controlled information throughout the lifecycle in compliance with relevant regulatory requirements. We passed the audit. We had no issues. That was just another feather in our cap for our decision to go with Content Server.

Senior IS Project Manager

Challenge

  • Network file shares created problems with information management
  • Lack of security and easy retrieval of data
  • No version control and or way to view audit trail
  • Needed to comply with FDA regulations in 21 CFR Part 11

Product(s)

Value

  • Secure repository for storing and distributing electronic documents with full version control
  • Web-based interface for team collaboration is easy to access and deploy
  • OpenText hosting environment simplifies management while addressing information security demands
  • Ability to audit and report on all actions
  • Compliance with FDA regulations in 21 CFR Part 11

About Non-Profit Organization - OpenText Cloud-Delivered ECM

This Coordinating Center facilitates the conduct of clinical trials to evaluate the safety and effectiveness of new therapies for a chronic disease that affects tens of thousands of children and adults around the world. The Coordinating Center promotes quality, safety and efficiency in the clinical trials by centralizing and standardizing the research process. The outcome of the centralized process is more efficient and effective trial design and execution, resulting in high-quality data leading to the development of potential new therapies.