Minimizing the Risk in Adopting eClinical Technologies: Five Ways to Spot Expertise

For all the personal and economic devastation it has wrought, the COVID-19 pandemic has at least brought about one positive change: a growing interest in, and acceptance of, decentralized clinical trials (DCTs) and the technology that supports them. The pandemic has catalyzed advancing the notion that not every clinical-trial visit has to be conducted in-person, on-site. With eClinical innovations, such as eConsent, tele-health, and direct-to-patient (DtP) shipment of drug products, DCTs are finally poised to go mainstream.

Many sponsors who’ve eyed DCTs from afar acknowledge that virtualization is the way of the future, and the industry is on the precipice of a fundamental change in how trials are conducted. There appears to be no reason, or will, to return to the way things used to be, as I’ve observed a general interest in continuing the momentum of the last year and a half.

Yet, sponsors in this risk-averse industry are often reluctant to take the plunge and invest in the technologies that make DCTs possible—in part because, in some cases, the technology is ahead of regulations. How can companies become comfortable in breaking out of the “late majority”, described in Geoffrey Moor’s Crossing the Chasm, to join the “early majority”, let alone the “early adopters” and “innovators”? Or, more to the point, how can sponsors minimize their risk in adopting eClinical technologies? Much of their success depends on their selection of technology partners.

Putting Expertise to the Test 
Sponsors concerned about the potential risks of adopting eClinical technologies to enable DCTs should seek out technology partners who are experts and can take the worry out of making the investment and implementing significant changes. But what does expertise look like, particularly with innovations that are still quite new? The following is a short litmus test that can be applied when selecting an eClinical partner:

• Does the potential partner exhibit a deep understanding of the business of clinical trials broadly and your clinical goals specifically? Or is the vendor unable to understand the impact of technical specifications and performance on the success of the trial as a whole?
  
• Can the potential partner see beyond its own proprietary system to appreciate the solution’s role in the larger trial workflow and overall development process, especially considering that a DCT trial might involve as many as 15 different vendors? This ability manifests itself in clear, transparent, simple processes; streamlined specification reviews; and expert advice on the technology, allowing the clinical team to focus on the trial goals.
  
• Does the potential partner understand the current regulations and how they apply to the technology solution? This entails beginning with the end in mind and acknowledging responsibility for managing data through to regulatory filing.
  
• Does the technology company play well with others? In other words, has the company established the requisite partnerships with other technology vendors, and does the company have significant experience in integrating systems for data flow and smooth operations?
  
• Does the technology provider have a robust quality system? Indicators of this include 1) rigorous oversight of internal processes, so they are audit-ready and anticipate any inspection-related questions, 2) embedded risk management practices that continually assess risk and prescribe measured actions, and 3) data-driven continuous improvement initiatives that have future trends in mind.

DCT trials will only catch on in the post-pandemic world if sponsors can adopt the associated technology with minimal risk. After all that the industry and humankind have been through with the pandemic, it would be a great loss if we are unable to turn what we’ve learned about operating remotely into an opportunity to re-invent trial operations. Sponsors, working with expert technology partners. can proceed confidently knowing that they will get the necessary guidance to minimize their risk and conduct a successful DCT trial.