Link

Medidata Link is a data linkage solution designed for clinical trial sponsors, study teams, and life sciences organisations that need to connect clinical trial data with real-world data (RWD) at the patient level. As evidence requirements evolve, regulators and payors increasingly expect a longitudinal view of patient outcomes spanning before, during, and after a clinical trial. Medidata Link addresses this need by enabling continuous, secure evidence generation that follows patients beyond the boundaries of traditional clinical trials.

By seamlessly connecting trials to leading U.S. real-world data ecosystems, Medidata Link provides an enriched view of the patient journey while managing consent and personally identifiable information (PII), and minimising site burden and cost.

Core Capabilities

• Flexible PII Collection across Trial Entry Points: Supports the collection of patient identifying information at multiple points throughout the trial lifecycle to facilitate accurate data linkage.
• Centralized Data Linkage Management and Token Creation: Provides a centralised hub for managing the linkage process and generating tokens that connect clinical and real-world datasets.
• Ongoing Consent Management and Compliance Support: Robustly manages consent status to ensure compliance with IRB and GCP requirements, including consent withdrawal management even after a trial concludes and sites are no longer accessible.
• Configurable Tokenization Technology: Offers full flexibility in the choice of linkage approach, supporting both de-identified (token-based) and identified (patient identifier-based) workflows, and is compatible with a wide range of tokenization vendors and RWD sources.
• Site Enablement and Operational Readiness: Provides support to prepare sites for data linkage activities, reducing administrative burden on clinical teams.

What Teams Gain with Medidata Link

• Long-term Follow-up: Maintains visibility into long-term effectiveness and safety outcomes even after trial completion by leveraging participants' real-world data. Reduces loss to follow-up and generates post-market, long-term effectiveness and safety insights without adding burden to patients or sites. Study teams can monitor patient activity through routine care data, preserving the integrity of trial endpoints even when patients do not return for scheduled follow-up visits.
• Label Expansion Studies: Supports the generation of evidence needed for label expansion by extending the data available beyond the clinical trial window.
• Confidence in External Control Arms: Enables the use of real-world data to construct and validate external control arms, strengthening study design and regulatory submissions.
• Value Evidence: Helps generate the health economics and outcomes data that payors require to assess the real-world value of a therapy.

Compliance and Data Privacy

• Consent withdrawal management is supported even after a trial concludes and sites are no longer accessible, ensuring data privacy standards are maintained throughout the patient journey.
• The platform is designed to meet IRB and GCP compliance requirements throughout the data linkage process.

Medidata Link is part of the broader Medidata Platform, which encompasses Data, Study, and Patient experiences as well as Professional Services. Medidata also offers a range of training options for clients and partners, including self-paced and instructor-led courses, available through the Medidata Global Education and Training programme.