How to Best Leverage Diverse Partners in a Virtual World
Mitch Collins, Adaptive Clinical Systems’ Chief Revenue Officer, Co-hosted a webinar discussion with Vince Puglia, Senior Director of Strategic Alliances at EndPoint Clinical, a leading global interactive response technology (IRT) company.
What is Frictionless Data?
The first challenge is to define just what Frictionless Data is and why is it important? Put simply, Frictionless Data is the ability to get data from any source in a trial to interoperate seamlessly, in real-time, bi-directionally with any other source or data destination. No silos, no delays, regardless of disparate formats and standards across systems. Data is our currency and it has to be freely exchanged.
The need for Frictionless Data is heightened by the accelerating adoption of decentralized clinical trials (DCT). Some consider DCT to be a COVID-induced phenomenon, but it is not. COVID has accelerated adoption, but the need for DCT existed previously. It has accelerated, but it is not new.
The move to DCT should be viewed through the lens of patient centricity. The patient IS the source of data. Trial design needs to begin at the patient and work back. If the patient can’t or won’t go to a traditional site, how do you design your trial to ensure that their data is captured? Do you send someone to them? Equip them with a continuous monitoring device? Or equip them with an episodic monitoring device that they can use unassisted? These and other factors complicate trial design, and require new approaches to trial design, data capture, and data interoperability.
Driving the Cultural Change
There was extensive discussion about the challenges of moving to this new normal environment. We believe strongly that the major challenge is not technical. While difficult, the technical hurdles can be overcome; doing so is the foundation of our company. Rather, it is cultural. New trial designs, new technologies, new challenges including regulatory and the impact of COVID require change. Company leaders need to ask hard questions about their existing business models, processes and especially, people. Do they have the right leadership in place to drive these changes?
A critical aspect of meeting the challenges of the new environment is the consideration of partnering and outsourcing. Our industry has traditionally been oriented more to build than buy, and there are many good reasons for this. Now the environment has changed and will continue to do so. No company, no matter how big, can be expert at everything. The skills to know what to build, what to outsource or buy, and how to weave them together are different than the old model. Again, this is a culture change issue.
If you would like to discuss these challenges (we have seen a lot of them), please reach out.