In 2015, the global eClinical software market was forecasted to reach $6.8 billion by 2020. Recent research now doubles that estimate by 2024. The global increase in clinical trials is driving this growth, as the industry evolves from its slow paper-based methods and standalone spreadsheets toward automated, cloud-based systems to confront the oft-mentioned costs of drug development.
The deployment of eClinical tools—EDC, eTMF, CTMS and Study Startup—play a distinct role in optimizing the full clinical trials process. Opportunities abound but none of these systems is a panacea.
Vendors hoping to expand their customer base and revenues have embarked on a standard business process of vertical integration, resulting in bloated eClinical tools that report to do everything but with caveats and gotcha’s—a diluted offering, lacking focus with an incomplete feature set.
Dangers lurk in an eClinical monopoly, best characterized by poor levels of service and consumer exploitation. Neither of which should be appealing to the industry that would essentially be fixing a problem by implementing another. While a “one-stop-shop” sounds appealing, it is simply not possible today. What works best is using and integrating a small number of tools that are purpose-build for specific clinical operations—a focus on combining “best of breed” applications verses relying on a one-size-fits-all approach.
To keep costs low, maximize competitive advantage and to speed the delivery of life-saving therapies to patients, the industry must leverage technology to accelerate clinical trials. The industry needs to be skeptical and wary of vendors reporting to provide replacement options for key components in the eClinical stack, which would, at best, lead to a monopoly but, at worst, be counter intuitive to the goals of deploying the software in the first place.
Guest Contributor Jae Chung is the founding visionary of goBalto. A startup evangelist, he works with Rock Health to mentor healthcare technology startups. He previously co-founded Celltrion, a leading biopharmaceutical manufacturing company and was a strategy consultant with McKinsey & Company.
This article was reprinted from Volume 24, Issue 11, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact email@example.com. Subscribe >>