Can I move an existing study to Veeva RTSM?

As an RTSM partner, Veeva RTSM works with sponsors and CROs to implement our solution for new studies. Sometimes, however, we are called on to help with unique scenarios involving studies that have already begun recruitment, such as the following:

  1. The study started collecting RTSM data in a simple solution (maybe even Excel), but the sponsor would like to move to a more robust system, especially if the study has expanded beyond its original scope.
  2. An existing study needs to be ‘rescued’ from the current provider due to significant technical or service-related issues.
  3. The current vendor could support the initial design, but a study amendment requires functionality that they are now unable to fully support.
  4. A study is being extended, and the sponsor would like to switch vendors for managing this extension.

The Veeva RTSM team has experience in navigating these scenarios and is well positioned to advise on available options.

Firstly, switching systems mid-study is not a decision that should be taken lightly. We appreciate that RTSM data is critical to the success of the overall trial; therefore, if this data and/or user experience is at high risk, it may be an effort worth undertaking.

Secondly, when considering the new solution, it is key to conduct due diligence and ensure the same challenges are not going to arise with the new vendor.

Migrating existing data and managing timelines is critical to all three scenarios. Using answers to the questions below as a starting point, our team will guide you through our recommended best practices and tailor our approach to your study circumstances.

  • How long has the study been in production?
  • How much data has been entered to date (#sites, patients, visits, shipments, used kits)?
  • Can the data be readily exported? In what format(s)?
  • How long does the study have remaining? Is it going to add value to change, or is there only a brief time left?
  • What existing connections are there to replicate?
  • Are there any new sites, countries, or depots to consider?
  • Will the same requirements for the existing system be applied, or is there an opportunity to improve any elements?
  • Is there an optimal time to make the switch (e.g., new cohorts, crossover, extension periods)?

Our configuration team will lead efforts to map and import data into Veeva RTSM and will discuss timing and the support plan for the transition period. This is a process that has been tried and tested on numerous projects to date. QC checks provide additional reassurance that all data is successfully included.

Clear communication with all stakeholders, especially with sites and shipping providers, is essential for a seamless switch.

So, if you find your study has outgrown its data collection methods, is amended or extended, or you’re considering switching vendors due to service challenges, contact the Veeva RTSM team to discuss the options.