The adoption of new technology, in any industry, follows a familiar cycle outlined by Geoffrey Moore in his book Crossing the Chasm,

• Innovators: Innovators are the first individuals to adopt an innovation. These individuals/teams are willing to take a risk to help advance a solution.
• Early Adopters: These are the teams that quickly adopt new technology faster than the majority of others, but they may not be on the front lines of innovation.
• Early Majority (eRegulatory is entering the final phases of this stage): They’re excited about new technology and they are genuinely interested in trying new things but they take longer before getting involved. Usually, they are waiting until the technology has proven itself before they dive in. They want other people to help the technology “clear out the bugs” and they want to be sure they aren’t wasting money on things that prove to be useless.
• Late Majority: The Late Majority users are folks that take on technology only when they must. By the time they begin using the technology it’s so ingrained in our culture that living without the technology would seem unrealistic or unlikely.
• Laggards: The Laggards are the final group of technology adopters. These are people that never purposefully adopt new technology.

This cycle has now matured to the late stages of Early Majority for eRegulatory/eSource for Clinical Trials. Innovative research teams have led the way in being frontrunners in the testing phase, and now the leading research centers across the country are actively adopting the tested and proven technology. As the adoption rate continues to increase and enters the late majority stage, having a purpose-built eRegulatory solution in place will essentially be a requirement for operating efficiently and attracting new industry studies.

The eRegulatory and eSource landscapes now feature robust technologies built exclusively for clinical research requirements and workflows. Specifically, these platforms provide solutions to research teams striving for better ways to get work done while improving compliance relative to HIPAA (for eSource work) and 21 CFR Part 11 (for eSource and eRegulatory).

At Florence we’ve seen the shift to maturity in this segment first hand. What used to be research teams saying “thank goodness someone finally built this” has now become “we’re actively building our eRegulatory and eSource strategy.”

Now that the industry has reached this mature state, the natural question is: What’s the hard benefit? Operational improvements from eReg and eSource save material time for sought-after research personnel and create an environment where study startup becomes more uniform. The result is that researchers spend more of their time doing research, and research managers harvest real operational cost savings and can take on more studies.

These concrete benefits become necessary requirements for research centers in the face of rising study volumes. For instance, a search on ClinicalTrials.gov reveals that there is more than 2x the number of immuno-oncology studies as there were 18 months ago. This pace of research is impossible without purpose-built tools.

Another important observation: when your team is working in a single tool, central management, once impossible, becomes possible. There is a real magic in how study and site-specific information is aggregated, compiled and shared when it’s all in one place.

What about sponsors? CROs and Sponsors are embracing eRegulatory and eSource to the benefit of their teams. The most progressive sponsors know that robust remote monitoring is impossible unless sites are provided tools for research task and document sharing.

Finally, the vendors themselves deserve mention. The eBinder category has attracted several companies who have embraced the need described here. This is both a market validation point and it highlights the presence of competition that creates a virtuous cycle of innovation for our collective customers. The industry is healthier because of this new community of engaged vendors.