Clinical trial stakeholders are increasingly using clinical trial software (‘eClinical’) solutions to smoothen and optimize the management and conduct of their clinical trial activities. 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, reaching $12 billion by 2025.
Maximizing productivity and lowering costs
Pharma/biotech companies, Contract Research Organizations (CROs), and hospitals are increasingly adopting digital solutions that supports them in streamlining processes, improving collaboration, and boosting trial efficiency and oversight. This trend is driven by a constant pressure to maximize productivity and lower the 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, money, and quality.
From general-purpose to purpose-built
As part of the industry’s digital transformation, organizations have increasingly been making the switch from general-purpose content management solutions and file stores (e.g. Microsoft Office) to advanced, purpose-built applications. To illustrate, the use of electronic Trial Master File (eTMF) solutions has quadrupled 2014, with more than half of the clinical trial stakeholders now using a purpose-built solution.
“The use of eTMF solutions has quadrupled since 2014, with more than half of the clinical trial stakeholders now using a purpose-built solution”
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, thereby leading to the streamlining of clinical trial activities and optimization of time and resources. By supporting clinical research professionals in their day-to-day activities, these solutions also help ensure compliance and inspection-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.
A 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.
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 workflows and activities. Unfortunately, many solutions still hamper adoption and usage 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 the time and effort usually spend on training new users while also promoting adoption on all levels of the organizations.
Lack of integration remains an 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 (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. 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 software solution ‘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 essential trial-related documents by establishing an immutable audit trail of their evolution over the course of a clinical trial.
According to an industry-wide survey by Veeva, the top drivers of eTMF optimization are ensuring a constant state of inspection readiness, better visibility, and automation of document tracking and reporting. Verial eTMF answers to these needs and the increasing calls for documentation as decreed by the US Food & Drug Administration (FDA), European Medicines Agency (EMA) and other regulators.
The Triall ecosystem, a multi-sided platform for clinical research
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-integrated back-end infrastructure will open up the possibility of connecting previously isolated eClinical solutions in a multi-sided platform. Using Triall’s APIs, existing eClinical providers get an easy entry to the blockchain functionalities within Triall’s infrastructure while also having the possibility to connect with Triall solutions and other third-party connected solutions.
Curious to learn more about our vision? We published a 3-part series on blockchain in clinical trials in which we dive into the unique opportunities offered by blockchain technology in tackling some of the persisting issues in today’s clinical trials. The first article of the series covers how blockchain can be used as a tool in promoting data integrity, traceability, and auditability. In the second article, we address how blockchain can be used to enable a tamper-proof and regulatory compliant infrastructure for digital identity and access management. And, lastly, in the third article, we explain how smart contracts can be used to govern data exchange, automate key activities, and improve compliance in clinical trials.