Transitioning your CRA team to Digital Site Management

/, eCTD, eRegulatory, eSource, eTMF, Remote Monitoring, Trial Site Regulatory eBinders/Transitioning your CRA team to Digital Site Management

Transitioning your CRA team to Digital Site Management

Over the last six months something interesting happened in usage data for eBinders, Florence’s eRegualtory and eSource platform, and by extension for study management in general. In April 2018 Clinical Research Associate (CRA) teams became Florence’s most active users. In fact, sponsor activity in the tool grew by nearly ten times Q4 2017 to Q1 2018.

Transitioning CRA to Remote Monitoring

What’s behind this transition?

Florence eBinders is a tool designed to help sites move to eRegualtory and eSource workflows in their clinical trials. In this move, sites get their day back from paperwork: eSignatures, alerts, reports and a common workspace for starting up studies all save time and allow research sites to scale.

So, given that eBinders was built for sites, what’s up with sponsor and CRO activity? As part of onboarding eBinders, our site customers invite their sponsor partners into the tool for remote task and document access. This keeps both the site staff and the CRAs out of email, and overall eliminates the paperwork back-and-forth common to most studies.

Indeed, now sponsor CRA teams have, by virtue of getting invited into eBinders from sites, made a transition many in our industry only talk about— they’ve moved to full Digital Site Management through 1) Digital study startup work and 2) Remote monitoring.

Transitioning your CRAs

If you’re a CRA, now’s the time to plan how your job is are changing because of digital study startup and remote monitoring.  So what should you prepare them for? According to Florence eBinder usage data, the three most common tasks in digital site management are:

  1. Document access – When sites complete essential documents, CRAs log into eBinders remotely for document collection, quality control, and submission to the trial master file
  2. Document creation—CRAs use eBinders to ensure sites have the correct version of version-sensitive documents: Protocols, informed consents, etc. They also distribute any document that requires publishing to multiple sites because one drag-and-drop movement can distribute a document, and verify acknowledgment, to hundreds of sites
  3. Project management tasks—As with documents, project tasks can be both confirmed and assigned in one place. CRAs are turning to eBinders to project manage through document management.

As a CRA, you should be preparing now for digital site management tasks including for document access, document creation, and project management, but what’s next? The short answer is: Data about site performance. Digital collaboration between sites and CRAs not only means easy access for managing tactics like document collection and task assignment but also for planning strategy through remote insights into what’s actually going on at sites between in-person monitoring visits.

In a future post, look for our analysis of the most important metrics for strategic study management, including:

  • Document cycle time
  • Query responsiveness
  • Startup forecasting
  • Accrual forecasting
  • Closeout forecasting

We’ll cover them in detail. Plus, if you have metrics you’re curious about, send us a message at florenceteam@florencehc.com.

Discover Florence eHub
2018-06-18T11:13:27+00:00

Leave A Comment