Gartner’s Michael Shanler was one of the first to recognize the trend of dClinical. He noticed that a new generation of software vendors was emerging who handled project management and reporting in a new way. Florence agrees with Michael’s observation, which is why we’re building tools that align with a dClinical approach.
An abbreviated history of project management for clinical research is useful for setting the context. Project management matured through three phases:
1) Spreadsheets and paper logs
Project management was first was anchored by spreadsheets (1990s). Excel was used by CRAs and coordinators to keep track of tasks and deliverables, as well as queries and resolutions.
Purpose-built software emerged in most industries in the 2000s. With the emergence of tools from Phase Forward, Medidata and GoBalto, the clinical research industry was no different. These ushered in the era of eClinical tools. Early eClinical tools presented a leap forward in productivity for both managers and their teams because the applications were built from scratch to do the job at hand.
They weren’t perfect, though. eClinical applications relied (and continue to rely) on research teams or CRAs to self-report tasks. For example, to process the receipt of a Form 1572:
- A box in the eClinical tool is checked by a Monitor to confirm its arrival
- The document is uploaded to a portal
- And finally, a text field contains details that the form is signed by the PI and other data about its review
By reading a report of that completed event, the program manager may decide to start enrolling patients at that site. But to communicate that milestone, the research team on site had to create a digital “shadow track” of what actually happened — the document’s presence, its signature status, and its availability are all recorded second-hand.
dClinical tools skip the shadow tracking and use the event itself, rather than a second-hand report of the event, to create study data for project management. This allows real-time tracking of events, where speed and visibility are improved immeasurably.
To further our example, let’s consider the same 1572 again. In a dClinical world, that document is signed and filed electronically in an eRegulatory tool. The signature and the document filing are recorded the instant they take place. The pedigree of the document (the who, what, when, where, and how) are written automatically to a digital audit trail.
A manager is aware the instant the task is complete and the report is generated. Plus by clicking on the data, the program manager gets instant, remote access to the electronic document itself for monitoring. Finally, a range of analytics can be generated about this event or those like it, such as how the performance of this site compares to its peers.
Why is this better?
- No delay. The instant an action is taken across any site, it’s reported to a central dashboard.
- Elimination of potentially erroneous interpretation at the site level. The task is not tracked and noted by a monitor or coordinator, it’s tracked digitally by the completion of the task itself.
- Instant remote access. With the right system, any datapoint can be the starting point for deep access to the document.
- A rich, auditable data stream that can enable deep analysis and identify areas for process improvement.
Florence makes tools that support sites and monitors and embrace a dClinical approach.
- Our eBinder Suite™ helps save site teams time in regulatory and source document management and delivers research center administration dashboards and reports for more compliant study management.
- Meanwhile, the Florence eBinder Suite™ for Sponsors equips sponsor and CRO teams to activate sites faster and to get visibility into site processes that’s impossible with traditional eClinical systems.
Pubget, Microsoft, BCG, University of California-Berkeley, Dartmouth College
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