Biopharmaceutical companies, Contract Research Organizations (CROs) and research sites are increasingly using clinical trial IT (‘eClinical’) solutions to smoothen and optimize the management and conduct of their clinical trial activities. As a result, the global eClinical market is expected to register an impressive CAGR of 13,6% over the coming years, reaching $12 billion by 2025.
In the last decade, clinical trial stakeholders have increasingly been making the switch from general-purpose content management solutions and file stores to advanced, purpose-built applications. To illustrate, the use of Trial Master File software has quadrupled since 2014, with more than half of the clinical trial stakeholders now using a purpose-built solution. This trend is the direct result of a digital transformation in the clinical trial domain, fueled by the rising preference for a data-centric approach and the ever-increasing volumes of data generated during clinical development.
The eClinical solutions currently on the market aim to replace manual, ad hoc and paper-driven procedures in clinical operations and facilitate decision-making in all stages of development, ultimately leading to an optimization of time and resources. Some of the most commonly used product categories are:
- Electronic Trial Master File (eTMF) solutions, used to store and manage all essential trial-related documents.
- Electronic Data Capture (EDC) solutions, used to record clinical data from research subjects.
- Clinical Trial Management Systems (CTMS), used for tracking progress and performance of certain trial-related processes.
- Randomization & Trial Supply Management (RTSM) solutions, used for the double-blind randomization of research subjects and the supply of investigational products or placebo accordingly.
“The use of eTMF applications has quadrupled since 2014, with more than half of the clinical trial stakeholders now using a purpose-built solution”
According to recent estimates, stakeholders involved in clinical trials use an average of six different eClinical solutions side by side. Ironically, the majority of these function-specific solutions are unable to communicate with each other. The few fully-integrated and all-encompassing eClinical platforms that do exist are often too costly for the smaller industry players (Academic hospitals, SMEs) and therefore this group, which makes up the majority of the total industry, is hampered by a lack of oversight of their clinical trial documents, processes, and activities.
Consequently, the clinical research industry is increasingly expressing the need for unifying the plethora of function-specific eClinical solutions currently offered on the market. According to an industry-wide survey, this need is driven by a demand for better visibility, more proactive risk mitigation and better study analytics and reporting.
The growth of the eClinical market and the need for unifying the eClinical solutions currently available provide Triall with ample opportunities. Triall’s blockchain back-end will open up the possibility of connecting previously isolated eClinical solutions in a multisided platform. Using Triall’s APIs, existing eClinical providers get an easy entry to the blockchain functionalities within Triall’s infrastructure.
Curious to know more about our means of integrating different eClinical solutions to blockchain and each other? Read about our plan and vision in the Triall whitepaper.