This is the ninth article part of our product spotlight series on Medium. In this article series, we walk you through the different software products and features of our end-to-end eClinical platform, focusing on one core product category each week. This week, we zoom in on our electronic Trial Master File (eTMF) solution.
Document management — a common denominator in clinical research
Researchers are required to build an electronic Trial Master File (‘eTMF’): the compulsory collection of documents that allows for the reconstruction and inspection of clinical trial operations, and their compliance with international quality standards and regulations. Building and maintaining an eTMF can be challenging since the eTMF often comprises thousands of documents, especially in multi-country trials that involve a large number of research sites. To illustrate, a recent industry-wide survey concluded that virtually all clinical researchers experience issues with keeping track of their documents and data in their clinical operations. Consequently, failures in document management are a persisting industry pain point, leading to significant trial delays, reiterations of research activities, and ultimately putting patients at risk.
Key features
In this article, we’ll walk you through the features and benefits of Triall eTMF as well as our current options for blockchain integrations and our current vision for decentralised identity and access management.
Benefits for clinical research professionals
Triall eTMF provides a single secure environment for managing all trial-related documents and ensuring inspection readiness throughout the clinical trial lifecycle. The application can be accessed from any device and virtually any location by authorised individuals at the sponsor-, CRO-, and Site-level. This means documents can be accessed, uploaded, reviewed, edited, and signed from laptop, tablet or smartphone. Moreover, researchers can leverage the prepopulated DIA TMF Reference model folder structure to speed up study startup and initiate document management tasks right from the start.
Platform interoperability
The Triall platform comprises a modular configuration of integrated clinical trial software (eClinical) applications for data capture, document management, planning & oversight, trial supply management, wearable integration, and more. All activities and processes running on our platform are therefore captured in real-time, including all documents stored in Triall eTMF and all data captured through Triall EDC, Triall ePRO, connected wearable devices, and more. Triall eTMF is available as an integrated module, which means that documents are stored, maintained, and accessed within a single secure cloud-based environment, or as a stand-alone application.
Triall’s Verifiable Proof API
Triall eTMF can easily be integrated with blockchain through our Verifiable Proof API which allows the timestamping of data, right at the moment where it is generated. These blockchain timestamps provide verifiable proof that a document was present at a certain point in time and has not been altered since. They therefore mitigate the corruption or manipulation of data at a later stage and improve the reliability of clinical science and good clinical practice (more info on verifiable proofs).
Creating verifiable proofs over the course of a study generates an immutable and verifiable audit trail that (1) lives independent of the systems used to collect data and (2) is kept available by a distributed network of computer servers (‘nodes’) who are incentivised to maintain the blockchain network. This means that long after a trial is concluded and applied eClinical systems have been retired, auditors and regulators can still verify the validity of the trial results.
Future vision
Triall is building a Self-Sovereign Identity (SSI) infrastructure that allows us to decentralise identity and access management (read how we are applying this in informed consent). This SSI infrastructure will provide users with greater ownership and control over their data, documents, and processes. In the context of Triall eTMF, this SSI infrastructure facilitates a switch from role-based permissions to attribute-based permissions.
Attribute-Based Access Control (ABAC) enables a highly granular approach to identity and access management where blockchain-registered Verifiable Credentials can be used to depict attribute-based policies related to authentication (e.g., single sign-on) and authorisation (e.g., signing of documents). These policies can use any type of attributes, such as user-level requirements, study metrics, and document status. ABAC can therefore promote operational excellence around important document management workflows and signing procedures.
About Triall
Triall brings Web3 to medical research by creating a digital ecosystem of blockchain-integrated software solutions that secure and streamline clinical trials. Triall’s solutions make clinical trials tamper-resistant and enable secure and efficient integrations between the many isolated systems and parties involved in clinical trial processes. Triall’s software is co-created with clinical trial professionals to ensure optimal user experience, solving actual industry pain points.
Visit the website: https://www.triall.io
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