The biopharmaceutical industry is embracing virtualization—and it is creating long-term opportunities for clinical trial technology and services providers.

COVID-19 made remote operations a necessity and reality for some of the world’s most risk-averse industries, and biopharma has unexpectedly emerged as one of the sectors transformed by this shift.

Before the pandemic, decentralized, hybrid and virtual clinical trials were limited. While the industry had embraced technology for years to administer in-person trials, and there were some early examples of smaller, virtual models successfully deployed, biopharma remained generally risk-adverse to embracing virtual trial models and associated technologies more broadly.

And with physical visits to clinical trial sites to perform compliance and data verification checks accounting for 40 to 60 percent of a Clinical Research Organization’s (CRO’s) revenues1, there were systematic and financial model barriers to drive change and support virtual trials.

But the pandemic changed everything. Within days, investigators and clinical trial participants were unable to connect in person, and virtual trials went from a tantalizing possibility to a necessity. To continue existing trials—and to safely support the new and urgent need for vaccine trials, the biopharma industry embraced virtualization—and it is creating long-term opportunities for clinical trial technology and services providers.

Solutions that support clinical study start-up, facilitate patient engagement and management, and automate paper-based processes are poised for strong growth.

Expanded potential for existing solutions

Pre-COVID proofs of concept and earlier experimentation had already shown that clinical trial data quality and patient adherence did not suffer under a virtual or decentralized clinical trial approach, and biopharma companies and their technology partners had already been developing supporting technologies. For example, LLR portfolio company RealTime and Suvoda, which serve the clinical research site and sponsor/CRO markets, respectively, are continuing to evolve their offerings to support virtual, hybrid and decentralized trials.

Over the past couple of years since the onset of COVID-19, the industry has begun to find a balanced approach to virtualizing more aspects of clinical trials, but realizing that, in most cases, neither entirely virtual nor entirely in-person trials is the right approach.  Solutions that support virtual visits, such as remote monitoring, participant engagement and remote data collection, are critical to enabling a growing trend in “hybrid trials,” where some elements are in-person and others are conducted remotely, bringing efficiency to the overall research process. Some example solutions to support hybrid trials include:

Wearable technology. Wearables made with flexible and hybrid electronics allow for the kind of continuous monitoring and automated data collection that can be vital to a clinical trial. At ActiGraph, where I am the board chairman, we provide wearable-based solutions that continuously measure motion and sleep for clinical trial participants and our solutions will soon also include heart monitoring. This data can be collected 24-7, providing longitudinal data that is inherently more valuable than episodic data collection, which is more easily affected by one-off factors such as a patient’s stress or energy levels that day.

Mobile self-reporting technology is eliminating the need for in-person visits and allowing for more continuous engagements during trials.

Self-reporting technology. Smart devices and mobile apps are allowing patients to self-report or answer surveys in near real-time to improve the electronic patient-reported outcomes (ePRO) element of any clinical trial. Not only does this technology reduce the frequency of required in-person visits but—as in the case of wearable technology—mobile self-reporting technology also allows for more continuous and immediate engagements.

Participant recruitment. Virtual and decentralized clinical trials have the potential to expand the pool of trial participants of both investigators and patients as traditional physical and geographic limitations are reduced or eliminated. Solutions that enable physician practices with the technology and process capabilities to participate in clinical trial research and can also facilitate access to a broader potential patient population, especially for rare and harder to cure diseases, are well positioned to succeed in the future.

Virtual meetings. The same virtual meeting technologies that support the delivery of telemedicine are enabling clinical trial researchers to meet with and monitor trial participants and collect qualitative data.

Participant Engagement. Participant engagement and compliance has become significantly more challenging in a decentralized environment and finding ways to improve the participant experience, reduce participation barriers, and reduce dropout rates will be critical to the success of the clinical trial.

Honing the value proposition of clinical trial technology

Biopharma companies are actively searching for technologies that will move them even closer to a decentralized and automated clinical trial environment to drive efficiencies and cost savings.

Five ways tech companies can prove they have the strengths and capabilities to be a valuable partner to the biopharma industry for virtual and decentralized trials:

Solid clinical trial data. While virtual solutions and automation can shorten development timelines and help bring drugs to market more cost-effectively, none of this matters if safety and efficacy suffer. Clinical trial technology companies must show how their solutions add value while meeting the same safety, efficacy and data quality standards of a traditional trial.

Proven cost savings. Any technology investment or shift in approach takes time, money and considerable effort. Vendors need to prove their solutions will result in significant savings to make the initial disruption worthwhile.

Finding ways to partner with CROs and deliver a win-win proposition can be critical to acceptance and adoption of a virtual trial approach.

Partnerships with CROs. Most traditional CROs have in-person processes baked into their approaches for delivering clinical trial services to their biopharma sponsor clients, and virtual trials compromise their revenue model. Because technology choices can be decided by trial sponsors or by CROs, finding ways to partner with CROs and deliver a win-win proposition can be critical to acceptance and adoption of a virtual trial approach. New service providers are emerging that have built their delivery models around a virtual paradigm and therefore traditional CROs must change their delivery approach if they are going to be able to compete in the future.

Easy integration. For vendors to be the most attractive partners to biopharmaceutical companies and CROs, their solutions must easily integrate with a wide array of complementary technologies. They should demonstrate through proven use cases that the data their solution collects or generates can be utilized and analyzed across a biopharma’s broader technology ecosystem.

Innovation. Decentralized clinical trials do not just address the challenges presented by COVID-19. They have the potential to transform the possibilities for biopharma companies. Virtualizing clinical trials means opening them to a larger pool of participants, including hard-to-reach or distributed populations, and securing the participation of physicians who are not in the regular pool of trial investigators. Technology companies that are able to visualize and build on these possibilities have an opportunity to help the healthcare system meet ambitious new goals.

Here’s the bottom line.

Biopharma was forced to participate in an industry-wide experiment in remote services delivery for much of 2020. It has accelerated adoption and shown the industry that virtual and decentralized trials are not only feasible but have the potential to significantly improve efficiencies and deliver new and valuable capabilities. The foundation has been laid: now technology and service providers need to hone their value proposition and demonstrate that they are ready to help both biopharma companies and CROs see success as they take the next step in this journey.

Learn more about the LLR team, relevant investments and our focus on Clinical Trial Technology.

 

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