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 built 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.
President and Founder
Jae Chung is the president and founding visionary of goBalto. A startup evangelist, Chung wants to change the way pharma and CRO companies initiate clinical trials. goBalto's purpose-built study startup SaaS solution allows stakeholders to better adhere to established timelines and budgets, with customers reporting reduction in cycle times by 30-plus percentage, thereby getting medicines to those in need faster.
Chung works with Rock Health to mentor healthcare technology startups, and previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company. Prior to Celltrion, he worked as a strategy consultant with McKinsey & Company.
In 2013 Jae was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has experience in drug development, commercialization, and business development. He has an MBA from New York University and holds a CPA.
Article published in CenterWatch, November 2017