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.
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.
FAQ
How does Medidata Link enable long-term follow-up without increasing site burden?
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.
Can Medidata Link help mitigate the impact of patients lost to follow-up?
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.
Is Medidata Link compatible with different tokenization vendors?
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.
How does the platform handle patient consent and regulatory compliance?
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.
Does Medidata offer training for its clients and partners?
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.