Previously, I discussed fixing clinical trial challenges with robotic process automation. This blog analyses site monitoring, and how robotic process automation (RPA) can enhance it.
While sponsors, CROs, and sites all acknowledge that site monitoring is a necessary part of ensuring clinical trials are run in compliance with governing regulations and protocols, it can be a rather burdensome process, both for monitors and for sites.
Monitors struggle with scheduling the visits, having access to everything they need during the visits, completing their reports, getting those reports reviewed and approved, and ensuring sites address any outstanding issues they identify.
Sites struggle with taking the time to prepare for and host the visits, as well as to address the follow-up issues, on top of the burden of running the trial and handling their regular patient load.
These struggles – on both sides – can be reduced by:
- Adopting a risk-based monitoring (RBM) approach, so that sites are only monitored when necessary
- Automating preparation and follow-up notifications
- Providing monitors with convenient tools that facilitate the monitoring process
- Streamlining report creation, review, and approval
- Automatically sharing relevant parts of approved reports with site personnel
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
One of the more thoughtful solutions to this issue works as follows:
Based on predefined clinical data and milestones, a site monitor receives a notification that one of her sites requires a site monitoring visit. She works with the site to schedule the visit, and both she and the site receive automated confirmation emails.
The day of the visit, the monitor arrives at the site with her iPad, which contains a proprietary site monitoring mobile app. She finds that the site’s wireless internet is down for the day, so she uses the app in offline mode.
Throughout the visit, she uses the interactive, decision tree-based user interface to address all of the topics, ask all of the questions, and record all of the answers. She even uses the iPad camera to take photos and attach them to the report.
After the visit, when she gets back online, the app syncs with the system, and she is able to issue the report for review. After receiving her manager’s feedback and making the adjustments, she routes the report for approval. The app allows her and her manager to apply 21 CFR Part 11-compliant digital signatures, and also maintains a complete audit trail of the report’s review and approval history.
Once approved, the details from the report that are relevant to the site are automatically shared with the site in a read-only capacity, and follow-up emails that include action items and due dates are automatically sent to all parties.
Combining risk-based monitoring with convenient and effective RPA technology can significantly improve the site monitoring experience, both for monitors and site personnel. The ideal approach minimizes the burden on all parties without compromising the quality of the monitoring process, which this solution accomplishes beautifully. And the collaborative and transparent nature of the process inherently boosts the monitor-site relationship.
To learn more about specific clinical trial challenges concerning the pharma-investigator relationship and potential solutions using robotic process automation, you can download the guide here, or fill out the form below.