Named Medidata Adjudicate, the new digital solution is designed to track all clinical events from start to finish. It helps gather, manage, categorise, adjudicate and submit data on clinical endpoints.
Investigator sites, contract research organisations, adjudicators, physicians, data managers, Clinical Event Committees, and sponsors can leverage the solution.
Medidata Adjudicate allows complete visibility into all trial events and status, along with flexible reporting for users to screen turnaround times and performance.
Users can also access self-service configuration of the solution to carry out their own trial builds, in turn maximising efficiency and control.
This is considered beneficial as many marketed solutions need a technology provider for the build, which increases development timeframes and costs.
A standardised process, clinical endpoint adjudication is used to evaluate the safety and efficacy of therapies in clinical studies.
The process is required to validate trial data when endpoints are subjective, complex or in case of a geographically broad study, Medidata said.
Medidata added that manual, paper-based adjudication processes are associated with increased time, costs and resource burdens on companies. These processes may also lead to errors, bias and regulatory issues.
Meanwhile, a centralised, digital adjudication system can help standardise clinical data and its interpretation, providing more reliable overall study data.
Medidata Adjudicate integrated with the company’s Clinical Cloud will enable compilation of all endpoint processes, as well as lower manual burden.
Medidata product executive vice-president, CTO and head Dr Rama Kondru said: “With Medidata Adjudicate, we’re able to help our customers and partners bring greater efficiency, accuracy, and value to the adjudication process in ways never seen before.
“This technology is intentionally designed to support trial integrity and it’s never been more important that sponsors, regulators, clinicians, and patients are able to trust the insights gleaned from clinical trials.”
In April last year, Medidata launched an advanced, intuitive platform called myMedidata for patients participating in clinical trials.