Powerful Mid-Study Change Utilities and No System Downtime

More than ever, clinical studies are becoming increasingly complicated and the likelihood of making unforeseen study modifications is all too common, no matter how well the study team prepares.

Implementing mid-study changes can be challenging if the eClinical system you are using is not strategically architected to optimize the implementation timeline and mitigate risk.

Optimize the Implementation Timeline

Recently, a Fountayn Sponsor Client had to implement a mid-study change adding an answer option on a feedback form. The Sponsor contacted the Fountayn Account Manager to initiate a change order to implement the update. Following standard change control processes, the Software Implementation Specialist was able to use system tools to implement the change. Once implemented, the Fountayn team tested the change, had the Sponsor perform acceptance testing, and pushed it into production.

“The total time to implement the mid-study change, from identification of the issue through placing the change into production, was under 2 hours, and required NO study downtime.”

Fountayn Platform, the complete suite of Fountayn products delivered entirely in the Cloud, enables this optimized implementation timeline.

When it comes to testing changes that have been made, the ability to test only the areas that are required can eliminate unnecessary review and drive efficiency. Fountayn incorporates tools that identify changes between versions allowing testers to pinpoint where changes were made, supporting targeted testing and reducing related time requirements.

The successful introduction of a change doesn’t end there. As changes occur, essential study documents such as blank and annotated eCRFs must be maintained and updated. System tools should be able to automate the creation of blank and annotated eCRFs, eliminating the labor- intensive task of manually maintaining these documents. Fountayn offers the tools needed to actively manage eCRFs and minimize related lost productivity.

Mitigating Risk

There is also associated risk for those systems that require data migration. For example, migration of data can fail or stop in the middle for any number of reasons, introducing new risk into the trial management process. Fountayn solutions do not require data migration, eliminating the risk potential introduced with data manipulation.

The Fountayn Platform implements mid-study changes with no required study down time, an optimized implementation timeline, and reduced risk, powered by our strategic architecture and the benefits of our Cloud- based solution.

*Fountayn Formerly known as Datatrak