What’s your eRegulatory Strategy?
In the last year we’ve met with dozens of research centers to discuss this question. We 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 and 2) the transition costs you’re willing to support. We’ll explore both 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.
Costs: Supporting eRegulatory. In order to have a successful rollout and capture the benefits above, your team must prepare for change. It’s up to you to kick off the change by communicating your new way of doing business to stakeholders inside and outside your building.
- SOP development: eRegulatory-specific SOPs must be developed to ensure a successful audit when the time comes. Your eRegulatory vendor should help your team with guidance and best practices for building these SOPs.
- Training: None of the benefits above are attainable without a training program and knowledge base that allows even the most technically timid user to feel comfortable going digital.
- Sponsor communications: Avoid surprising your sponsor partners with the digital transition. A planful sponsor communication program avoids surprise and communicates your SOPs in an effective way.
- Agency communications: Prep for an audit. The FDA’s guidance on eRegulatory can be boiled down into two points: 1) Make sure your eRegulatory system is 21CFR Part 11 compliant. 2) Ensure your team is ready to use the system to walk an auditor through your documents and audit trail.
Where to from here?
Your site should develop a view on eRegulatory strategy whether you’re ready to buy a purpose-built system or not—this analysis can expose hotspots that you may be able to solve first with SOPs, and it can illuminate the total scope of a possible eRegulatory project. This initial review requires three tasks:
- First, analyze and rank the benefits you seek from the transition.
- Then, ask what costs could the transition to digital pose to your site.
- Finally, consider how you would manage the costs to make it a reality: Which can you handle, and which require help from your vendor or consultant?
It can be as simple as that: analyze the benefits that are most important to you and the costs that must be managed to get there. Congrats, you have an eRegulatory strategy!
Pubget, Microsoft, BCG, University of California-Berkeley, Dartmouth College
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