Medidata has come up with a way to link patient-level clinical trial results and real-world data (RWD) to improve patient safety and overall study outcomes.   

Medidata Link is powered by and fully integrated with the Medidata Unified Platform, providing any clinical trial run on Medidata Rave EDC (electronic data capture) the option to conduct data linkage.

Medidata Link helps sponsors, trial sites, and patients to:

• Gain a head start in evidence generation: Begin collecting real-world patient-level data during the trial to jump-start evidence generation and patient insights; for completed trials, RWD sets can bolster patient-level data about specific participants, rather than waiting for general RWD to accumulate after launch.
• Enhance data collection beyond a single trial: Track longer-term patient outcomes, safety, and insights not captured within the finite period of the clinical trial, to generate evidence to support payor and provider discussions; fill gaps for unanticipated questions, or understand outcomes for patients lost to follow-up.
• Reduce patient and site burden: Reduce the need for burdensome follow-up visits, leading to lower patient attrition and reduced burden for sites.

 
“Medidata Link provides the opportunity to enhance evidence generation activities, including needs that were not originally anticipated, which allows sponsors to collect trial data and connect it to patients’ RWD,” said Sastry Chilukuri, co-CEO of Medidata. “This transformational capability bridges evidence gaps, and helps create the insights necessary to save time and bring more confidence in clinical decision making.”
 
Medidata Link enables customers to generate a “token” to connect the patient’s clinical data in the Medidata Unified Platform to the industry’s broadest RWD ecosystem in a secure, compliant, and scalable manner. Medidata facilitates the de-identification process by providing a user-friendly collection process for Personally Identifiable Information (PII) through site-facing capabilities and the myMedidata patient portal. This creates a seamless integration with the rest of the clinical trial workflow and is agnostic of consent methods. The solution protects sponsors from the risks of directly holding PII, while streamlining third-party data privacy certifications so that only certified data is transferred to sponsors. Medidata is partnering with HealthVerity and Datavant to establish pre-built integrations to enable this de-identification and linkage to a broad RWD ecosystem.
 
Medidata Link offers a significant opportunity to better understand a patient population and therapeutic outcomes before, during, and after the trial. By connecting patients participating in a trial to RWD, drug developers can save years by not having to wait until the trial concludes to start generating real-world evidence (RWE) that can inform medical and future pipeline decisions. Unrivaled in analytics, clinical and commercial expertise, Medidata allows sponsors and CROs to generate the best evidence and insights from their connected data.
 
Medidata is a wholly owned subsidiary of Dassault Systèmes.