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Whitepaper: Maximizing Resources throughout the eTMF Lifecycle

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Maximizing resources for emerging sponsors, who are often relying heavily on outsourced partners, can be a challenge. 

This whitepaper will cover these key topics:

  • The difference between a system and a process
  • The importance of assigning tasks
  • How to leverage technology to support the study narrative

Here is a short sample from the whitepaper...to view the complete guide, fill out the form below

Maximizing Resources Throughout the eTMF lifecycle

Three key areas to consider when managing data in a resource-heavy environment

Clinical data can be a resource-intensive process, especially for emerging life science organizations that lack the budget to hire staff to manage the multitude of different tasks and processes involved. To comply with regulations and work collaboratively, organizations should ensure their processes are not overly burdensome, assign responsibilities to the right people, and take advantage of the efficiencies that modern software systems offer.

1. Keep processes simple and streamlined

The electronic Trial Master File (eTMF) system is a tool to support trial management, but it's not a process itself. Efficient processes are what drive systems, and the implementation of an eTMF can be a prime opportunity to enhance your workflow and make it more efficient. The benefits of doing this are twofold:

  1. To help ensure that processes are optimal for the new system
  2. To enable organizations to take advantage of its full functionality

However, many organizations continue to rely on legacy systems when implementing technology, leaving the efficiencies of modern systems off the table. As a result, they have processes that require manual intervention because they don’t follow the way organizations complete their work in today’s world.

Maximizing resources requires a comprehensive analysis of every step in the workflow. Starting with an internal process audit will ensure that they are working as they should and that organizations are getting the most out of system features. Once corrective action has been taken to address the issues identified in these audits, it is vital to...

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