Triall Product Spotlight: CTMS

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This is the fourth article part of our new 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 the features, benefits, and integration options of our Clinical Trial Management System (CTMS).

CTMS solutions
Clinical trials are increasingly complex, involving more research sites, more participants, and more data. To illustrate, a typical Phase 3 clinical trial can comprise 50 sites across 15 countries. This underlines the need for clinical trial software (‘eClinical’) solutions that support with maintaining operational oversight throughout a study, with the most prominent one being the Clinical Trial Management System (CTMS).

A CTMS provides a centralised view of study progress and performance across all participating research sites. It offers a comprehensive set of project management tools that support the study team in all clinical trial phases — from study startup to execution and close-out. According to an industry-wide survey, the top drivers for using a CTMS are improved study analytics and reporting, better trial visibility and oversight, and more proactive risk identification and mitigation.

Key features
In this article, we’ll walk you through the features and benefits of Triall CTMS as well as our current options for blockchain integrations and future vision for decentralised identity and access management.

Benefits for clinical research professionals
With Triall CTMS, clinical research professionals can harmonise clinical trial management and oversight for all key study activities. Powerful reporting and analytics capabilities enable the tracking of study progress and performance across all research sites. Furthermore, you can build and export custom reports for advanced analytics and reporting of key performance metrics in other business intelligence tools.

Moreover, researchers can easily manage their regulatory workflow by collecting and accessing all site documentation and study data in a singe place. In addition to that, Triall CTMS allows them to define document completion rules to track site enrolment and they can use the application to quickly build and deploy study-related forms such as protocol approvals, delegation logs, financial disclosures, and more.

Lastly, our CTMS<>EDC integration enhances productivity and collaboration between authorised study team members — where highly configurable role-based access permissions ensure security and compliance — and it also enables automated site payments based on pre-defined rules and conditions (e.g., as sites complete data entry).

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. The data captured through Triall CTMS can therefore directly be stored, maintained, and accessed within a single secure cloud-based environment. Triall CTMS is therefore also integrated with Triall EDC, Triall ePRO, connected wearable devices, and more.

Triall’s Verifiable Proof API
Triall’s CTMS can easily be integrated with blockchain through our Verifiable Proof API which allows the timestamping of data, such as relevant study performance metrics, right at the moment where it is generated. These blockchain timestamps provide verifiable proof that data 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 participants, researchers, and other platform users with greater ownership and control over their data, documents, and processes. In the context of Triall CTMS, 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), authorisation (e.g., digital signatures), data discovery, and data exchange. 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 processes such as managing the delegation log and tracking training credentials across the study team.

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.

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