What’s your eRegulatory Strategy?
In the last year we’ve met with dozens of research teams to discuss this question. In the process, we’ve discovered that moving to an eRegulatory platform is much more than moving from paper to digital documents.
Formulating a site-wide strategy for eRegulatory means considering 1) the benefits you seek, 2) the transition costs you’re willing to support and 3) the integrations that must exist with your other technologies. We’ll explore those here.
Benefits: The Impact of eRegulatory
Getting rid of paper isn’t the reason to pursue an eRegulatory strategy. Instead, the benefits of eRegulatory are expressed by how your team improves once it moves on from paper. The positive changes fall into these categories:
- Team specialization: Today’s best organized sites don’t ask their coordinators to do it all. Instead they specialize with regulatory, contract, and startup project managers. A purpose-built eRegulatory tool allows such specialization to take hold through workflows built for each role.
- Team location: Allow your team to work remotely, or take on multicenter research sites—no matter their location. If your solution has eSignatures and tasks, location no longer matters.
- Efficiency: Save time across document filing, signature requests, study tracking, and document review tasks. Ask your eRegulatory vendor how time savings are measured, and across what tasks specifically, so you can estimate the savings at your own site.
- Monitoring management: Let your team manage monitor visits on your terms. This means controlled access for remote monitoring, and a safe place to aggregate EHR records, lab reports and other source for monitor access.
- Reduced risk of audit findings: Moving from half-paper, half-digital processes allows your team to get one version of the truth and cut compliance risk. Your admin team can monitor compliance via reports, impossible to assemble with spreadsheets and binders.