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Don’t Forget to Check Under the Hood: A Study Start-up Application is Only as Good as Its Underlying Platform

Many different systems, from EDC and eSource, to eTMF and CTMS, among other applications all contribute to study start-up. But distinct systems on different platforms cannot communicate directly with one another, duplicate information is created, and it is difficult to get a full picture of the start-up process. The administrative burden for inputting data, requesting information, and uploading documentation is also significant.

Leveraging a study start-up application on a common platform with these other clinical systems allows sponsors and CROs to unify clinical operations and better manage the start-up process (see our previous blog on the benefits and value of having a unified clinical environment). When evaluating a study start-up application, it’s equally important to review the platform it’s built on. The three most important elements to consider are the platform’s flexibility, fit with other essential applications, and its ability to grow.

Flexibility
Flexibility allows the study start-up application to adapt to an organization’s unique requirements, as well as support changing regulations and processes. To begin, determine what functionality is “hardcoded” in the application (i.e., cannot be changed) versus what is configurable. It’s important for the platform to be configurable and not require complicated code to customize, which can have a downstream impact on future upgrades and make it more difficult to use future enhancements.

In order to ensure proper flexibility, make sure the platform can:

  • Easily extend data to track and store fields, objects, and relationships
  • Modify the system to guide users and optimize how they interact with the system
  • Provide configurable reporting
  • Fit with other essential applications
    When looking at how a study start-up platform fits with your other applications and systems, it’s beneficial to not only think of study start-up as an end-to-end process, but to conceptualize it as part of an end-to-end clinical trial process. Even if the current focus is a point solution, looking at the bigger picture will help ensure you don’t get stuck later. If the platform doesn’t fit with your systems it will result in manual workarounds, inefficient processes, and silos of information.

    A platform should have:

  • A comprehensive set of published APIs that are well documented and supported when the product is upgraded
  • Additional products built on the same platform so you can add components without the cost of building integrations
  • Ability to grow
    Most life sciences organizations have an expectation to grow over time as their development portfolios mature or partnerships deepen. Planning for this future trajectory when evaluating a platform ensures your technology will support you as more users are added and processes become more complex.

    A study start-up platform that has the ability to grow to meet your evolving needs should have:

  • A proven record to scale and perform
  • Continual investment to evolve the platform
  • A track record of delivering improvements
  • While this is not a comprehensive list of everything to evaluate when looking at a study start-up application and platform, it should help you start to determine whether the underlying platform suits your needs. Looking at the whole picture with an eye to the future and ensuring you are flexible enough to adjust quickly will help you get the most value out of your study start-up investment.

    To learn more, read how inVentiv Health has unified their study start-up processes and clinical operations on the Vault Platform to accelerate site activation.