Why are you Paying for End-of-Study Media for Your Clinical Trial?
The process of archiving data at the end of a clinical trial has not changed in many years. Even where the process has been improved with technology, it still requires a considerable number of manual steps.
A typical process for end-of-study media usually flows something like this:
- Lock the database
- Generate the PDFs for the subject casebooks
- Burn these PDFs to CD/DVDs or save them to USB sticks, one for each site
- Send all media items to each site along with an acknowledgment form through the postal service
- Receive acknowledgment forms back from every site to confirm they received the files and have stored them securely
Often studies will utilize a number of sites, so this process can take a long time to complete. Creating individual copies for every site manually is laborious and collecting acknowledgment forms often gets overlooked because, at this late stage of the process, everyone has moved on to their new study.
Vendors have tried to address the ongoing issues through different means but often fail, which can require them to pay for expensive service contracts to map data into their software. In extreme cases, some have had to fall back on the inefficient and manual process of burning PDFs on CD/DVDs. Due to the logistical scale of the task, human error often creeps in and becomes the source of audit findings. This results in additional high costs to fix.
Veeva Vault EDC takes a different approach to the end-of-study media problem. With Vault EDC, you create PDFs for a site with the click of a button as soon as the data for that site is locked – even if a site needs to drop out early, they do not need to wait until the end of the study. Sites are notified by email when their PDFs are ready for download. They log into Vault to download their file and are automatically prompted to send an e-signed acknowledgment.
Another advancement in Vault EDC is the reporting view showing the status of the overall process. Data managers can log in and see at a glance which sites have not downloaded their files or sent back the electronic acknowledgment. Reminder emails can be sent to sites with one click. There is also an oversight report that shows the status by site and can be scheduled and delivered daily to the data manager’s email inbox.
Lastly, the end-of-study media process has to occur for every study. So why is it that so many vendors charge additional fees for handling this necessary step? As part of offering a “better EDC” Veeva includes these capabilities at no additional cost.
The benefits are significant and proven. Learn how KCR, an international, full-service CRO, is using this capability to improve its efficiency and compliance.
Learn more about what Vault EDC can do to help your company streamline your study cycle times.