Medidata, a Dassault Systèmes company, today announced the launch of the Medidata Decentralized Clinical Trials (DCT) Program, the most comprehensive set of unified, secure technologies that enable full decentralization across the clinical trial continuum. For the first time ever, drug, vaccine, and medical device developers (sponsors) and contract research organizations (CROs) can take advantage of the only platform offering on the market which combines:
Technology and workflows to virtualize patient participation
Tools that facilitate sponsor oversight of patient safety and data quality
Direct-to-patient services, including facilitation of delivery of study drugs to the home
The Medidata DCT Program captures participant data remotely from anywhere, at any time. It aggregates and transforms that data, monitors the data to identify quality issues to mitigate risk and ensure patient safety, and runs powerful analytics to draw new insights leading to better outcomes for patients, researchers, sites, sponsors, and CROs.
"The life science industry has seen accelerating interest and adoption of decentralized trial technology in the wake of the COVID-19 pandemic," said Anthony Costello, president, patient cloud at Medidata. "Sponsors and CROs are increasingly turning to decentralized trial models in an effort to bring increased efficiency, security, and accessibility to the clinical research process."
Through a range of capabilities on a common platform that can be individually turned "on" or "off" in various combinations using the Trial Dial™ concept, the Medidata DCT Program provides the highest level of customization of decentralizing solutions based on study protocol design. This allows study sponsors to adjust and choose everything from traditional onsite trials, to fully decentralized models, and every hybrid trial design in between.
The Medidata DCT Program revolutionizes the paradigm of sponsor study oversight by supporting sponsors and CROs to easily adopt risk-based approaches to study execution, rather than historically reactionary and inefficient on-site practices. Embedded capabilities for risk identification, monitoring, and mitigation allow for truly digital oversight, where physical and virtual interaction with sites can be optimized while maintaining patient safety and data quality. The Medidata DCT Program also allows for powerful workflows driven from patient-centric data, such as shipping investigational product directly to the patient and automated dosage adjustments.
"We are very proud to say that, as a trusted partner to the life science sector for more than 20 years, Medidata is now the only company providing a full suite of virtual capabilities to enable complete trial decentralization, encompassing both patient and site interactions," added Costello. "The DCT Program marks an important evolution in Medidata's vision for how we can better serve patients and customers, by accelerating research and bringing novel therapies to market in record time."
To date, Medidata has applied its decentralizing technologies across more than 44,000 clinical sites around the world in multiple languages involving more than 600,000 patients with a wide array of illnesses. Nearly 350 sponsors and CROs have trusted Medidata to handle the increasing speed and volume of electronically sourced patient data generated by modern trials. The single platform minimizes the opportunity for data discrepancies and transfer lags, which can lead to security concerns and increased risk of trial disruption.
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