Triall Product Spotlight: EDC
We’re excited to introduce the new Triall 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 Electronic Data Capture (EDC) solution.
Clinical trials generate vast amounts of safety and efficacy data from a growing number and variety of sources. This underlines the need for effective tools that enable the secure and efficient collection of data. Over the past two decades, Electronic Data Capture (EDC) solutions — computerised systems used for collecting clinical data — have gained increased popularity among pharma companies, contract research organisations, and hospitals as the industry switched from paper to electronic records.
According to an industry-wide survey, EDC solutions are the most leveraged product category within the clinical trial software (‘eClinical’) solution domain, with virtually all stakeholders using or looking to use a function-specific EDC system. These solutions help promote efficiency, data quality, and regulatory compliance, and thereby significantly reduce the time and costs of clinical development.
In this article, we’ll walk you through the features and benefits of Triall EDC 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 EDC, clinical research professionals can rapidly build, deploy, and manage study forms from any device and any location. Our advanced drag-and-drop builder allows users to configure their form variables with maximum flexibility, including condition-based logic and permissions based on study randomisation or other subject- or visit-specific criteria. Moreover, researchers can easily replicate and repurpose existing forms, variables, and conditions in between different studies, eliminating the need for repetitive tasks. They can also use study version control to manage protocol changes without having to migrate data or create a new study environment.
Triall EDC includes an integrated query management system, which includes a complete audit trail and can be used to perform form-, field-, and interval-based queries via web or mobile. Lastly, users can easily access summary information for each individual patient and can navigate between different visits and forms for efficient lookup and oversight.
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 EDC can therefore directly be stored, maintained, and accessed within a single secure cloud-based environment. This furthermore means that Triall EDC also collects data from Triall ePRO and connected wearable devices.
Triall’s Verifiable Proof API
Triall EDC 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 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.
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 our EDC solution, this SSI infrastructure can be used to distribute data ownership rights between the clinical trial sponsor and the participant. This means that participants could have the opportunity to monetise their data for future research purposes. Within the emerging data marketplace, TRL can function as a common currency enabling the automated distribution of (micro)payments across clinical trial sponsor and participants.
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