While presenting at Central Monitoring Summit 2018, Elizabeth Robinson of Horizon Pharma shared a strong data point: In the coming years, Clinical Research Associates (CRAs) will experience more change to their jobs than any other research profession (2017 Applied Clinical Trials survey). This statement spurred a conversation amongst the room about what will change and left open questions about how technology will support the CRA workforce.
The session first analyzed the difference between traditional CRA monitoring tasks and future CRA monitoring tasks. Traditional CRA tasks are in person and on-site. They include:
- Drug reconciliation
- Source Data Verification (SDV)
- Essential document inspection
- Detection of risks and development of queries
But as their roles change, CRA’s must perform these tasks offsite and will need to manage automated tasks. Future CRA tasks include:
- Remote SDV as via Electronic Data Capture (EDC) software and risk-based monitoring tools
- More frequent site contact – 200% greater site contact frequency than in the past, but using phone calls and emails
- Less frequent onsite visits, with a different focus: More time will be spent building relationships, promoting GCP and aiding understanding of the protocol onsite— in contrast to traditional inventory and document review tasks
- Working with a separate central monitoring team that is wholly responsible for data review, taking SDV and essential document tasks of the CRA’s plate altogether
In the session, discussion of technology supporting the CRA’s transition was largely absent. Only the old standbys were mentioned: Excel, email and teleconference tools.
What a shame, the costs of this unsupported transition are real for CRAs and sites. We’ve documented the burden to sites and CRAs in managing remote monitoring with these tools, for more information look at our impact of remote monitoring whitepaper here.
Instead, a site access and remote monitoring platform should support the CRA’s transition. Such technology should:
- Streamline remote data provisioning, aggregation, and review
- Capture data from numerous, siloed sources
- Speed time-to-answer for FDA and other inquiries
- Incorporate workflow tools and reporting tools for the research team and the CRA
We can help. When job roles change, the underlying infrastructure must change too, and at Florence we’re working to help. Florence eHub provides a toolset that supports the CRA in remote startup, remote monitoring and remote quality control (QC) tasks. eHub helps get project management and review tasks out of email and into a shared, single view of the truth for both the CRA and site coordinators.