Link

As evidence requirements continue to evolve, regulators and payors expect a more complete, longitudinal view of patient outcomes—before, during, and after a clinical trial.  

Medidata Link securely connects clinical trial data with real-world data (RWD) at the patient level, enabling continuous evidence generation that follows patients beyond traditional clinical trials for an enriched view of the patient journey.

Download Overview
Video transcript: Bringing safe, effective treatments to patients as quickly as possible is the desire for everyone involved in a clinical program. While there have been incredible gains, there's always more that can be done. We can always be better, including when it comes to understanding a patient's journey before, during, and after a clinical trial. Clinical trial data and real world data each provide insight and serve a vital purpose in advancing drug development, monitoring safety and improving patient outcomes. But up until now, they've existed in disparate silos. What if there was a bridge that could connect the two? A bridge that could unlock more powerful insights for the next generation of clinical development. Medidata Link is that bridge. Medidata Link is the first centralized solution that easily connects your clinical trial data to real world data at the patient level. Powered by and fully integrated with the Medidata Clinical Cloud Platform, enabling you to securely collect and manage patient information without additional burden to you, your patients or sites. Metadata's industry leading patient privacy processes ensure information is always protected, keeping data collection safe and secure so you can focus on evidence generation, outcomes analysis, and progressing clinical development. Meddata Link expands your view beyond the confines of a single clinical trial and powers longitudinal insights into safety and effectiveness data, health care resource utilization, and long term outcomes, so you know how your treatment is truly impacting the lives of those you treat. Providing your team with a richer view of the patient journey, understanding their path before the trial, during the trial, and how their journey continues beyond the trial, allowing you to gather meaningful clinical endpoints even for patients lost to follow-up. To generate evidence so your therapy gets into market and to the right patients faster, helping providers make better decisions and developing the next round of treatments. Sponsors are already embarking on this journey to future proof their trials and drive towards the next frontier in clinical development. By combining the power of clinical and real world data, you can bridge evidence gaps and unlock a view of patients never before possible, creating insights that save you valuable time and instilling you with a new level of confidence in clinical decision making.

Link Clinical Trials to Real‑world Data

Seamlessly connect trials to leading U.S. real-world data ecosystems while managing consent and PII, and minimizing site burden and cost.

Flexible PII Collection across Trial Entry Points
Centralized
Data Linkage Management and Token Creation
Ongoing
Consent Management and Compliance Support
Configurable
Tokenization Technology
Site Enablement and Operational Readiness

What Teams Gain with Link

Long-term Follow-up

Extend Long‑term Follow‑up

Maintain visibility into long-term effectiveness and safety outcomes—even after trial completion—by leveraging participants’ real-world data. 

Reduce loss to follow-up and generate post-market, long-term effectiveness and safety insights without adding burden to patients or sites.

Download Fact Sheet

More Resources


Explore deeper guidance and related materials.

View All Resources

FAQ

By linking clinical trial data to real-world data (RWD), sponsors can collect data on long-term effectiveness and safety outcomes even after a trial completes. This approach facilitates post-market and safety monitoring studies without requiring additional visits or administrative work from patients and sites.

Yes. The solution allows study teams to monitor patient activity through their routine care data. This provides expanded insight into treatment and outcomes even when patients don't return for scheduled follow-up visits, helping to preserve the integrity of trial endpoints.

Yes. Medidata Link offers full flexibility in the choice of linkage approach, supporting a wide range of RWD sources and tokenization vendors. It can support trial linkage through both de-identified (token-based) and identified (patient identifier-based) workflows.

Medidata Link robustly manages consent status to ensure compliance with IRB and GCP requirements. It supports consent withdrawal management even after a trial concludes and sites are no longer accessible, ensuring that data privacy standards are maintained throughout the patient journey.

Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.