Clinical trial stakeholders are increasingly using clinical trial software (‘eClinical’) solutions to smoothen and optimize their clinical trial operations. As a result, the global eClinical market is projected to register an impressive compound annual growth rate (CAGR) of 13,8% over the coming years, a growth that is likely to be even bigger due to the digitalization push caused by global lockdowns and restrictions.
Article summary
- Clinical trial stakeholders are adopting digital solutions to streamline processes, improve collaboration, and boost efficiency and oversight.
- 98% of industry professionals express the need for unifying the plethora of function-specific eClinical solutions currently offered on the market.
- Triall’s first product ‘Verial eTMF’ is a blockchain-integrated document management solution designed to streamline and secure filing workload.
- Triall’s blockchain infrastructure will open up the possibility of connecting previously isolated eClinical solutions in a single digital platform.
Maximize clinical trial productivity and lower costs
Pharma companies, clinical research organizations, and hospitals are increasingly adopting digital solutions that supports them in streamlining processes, improving collaboration, and boosting efficiency and oversight. This trend is driven by a constant pressure to maximize productivity and lower the overall costs of clinical development. eClinical solutions can provide a competitive edge to clinical trial stakeholders by helping boost their operational effectiveness in terms of time, resources, and operational excellence.
From general-purpose to purpose-built solutions
As part of an industry-wide digital transformation, organizations have increasingly been making the switch from general-purpose solutions (e.g. Microsoft SharePoint) to advanced, purpose-built applications specifically designed for clinical research. To illustrate, the use of electronic Trial Master File (eTMF) solutions quadrupled from 2014 to 2018, with the majority of clinical trial stakeholders now using a purpose-built solution (source).
Most commonly used eClinical solutions
The eClinical solutions currently offered 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. By supporting clinical research professionals in their day-to-day activities, these solutions help streamline clinical trial activities, optimize time and resources, and ensure compliance and inspections-readiness (when used accordingly).
eClinical solutions have therefore become an essential part of clinical development and have a large impact on the timelines and costs of clinical trials globally. 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 and placebo accordingly.
Most important selection attributes
An industry-wide survey by ISR shows that data security is considered as the most important selection attribute by professionals looking to onboard a new eClinical solution in their workflow. This is followed by overall ease of use, possibilities for integration with other eClinical solutions, and auditability (all attributes that know a key focus in the Triall ecosystem).
Daunting user interfaces and complex instructions
After onboarding the application, staff needs to be trained on how to properly and most effectively integrate the eClinical solution in their day-to-day operations. Unfortunately, many solutions still hamper adoption due to daunting user interfaces and complex instructions. With the increasing interest in UI/UX design, the industry is moving forward and eClinical solution providers are starting to increasingly focus on optimizing user experience. This promises to significantly reduce time and effort usually spend on training while also promoting adoption on all organizational levels.
Lack of integration remains a pressing issue
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 small-to-medium-sized industry (the majority of the market) and therefore this group is hampered by a lack of oversight of their clinical trial activities.
Consequently, 98% of clinical research professionals is expressing the need for unifying the plethora of function-specific eClinical solutions currently offered on the market. This need is driven by a demand for better visibility and oversight, more proactive risk mitigation, and better study analytics and reporting.
Verial eTMF, a blockchain-integrated document management solution
Triall’s first product Verial eTMF is a blockchain-integrated document management solution that supports clinical research professionals in building and managing their eTMF. It is designed to ease and streamline filing workload by promoting document management, oversight, and reporting. Uniquely, it also enables the user to prove the existence and authenticity of their trial-related documents by establishing an immutable audit trail of their evolution over the course of a clinical trial. It thereby answers to calls for increased data auditability and transparency as decreed by the US Food & Drug Administration (FDA), European Medicines Agency (EMA) and other regulators.
A digital ecosystem of blockchain-integrated eClinical solutions
The growth of the eClinical market and the need for unifying the eClinical solutions currently available on the market provide Triall with ample opportunities. Triall’s blockchain infrastructure will open up the possibility of connecting previously isolated eClinical solutions and their users in a single digital platform. Using Triall’s APIs, existing eClinical providers get an easy entry to the blockchain while also having the possibility to connect with Triall solutions and other third-party connected solutions.
Curious to learn more about our vision? Check out our website triall.io
