Medidata Link is a software solution that facilitates the linkage of clinical trial data with real-world data (RWD) at the patient level. This innovative tool creates an enriched view of the patient journey before, during, and after trial completion, generating valuable insights that accelerate patients' access to innovative treatments while minimizing site burden and costs.

Key Features

Easy Implementation Seamlessly integrates into trial workflows with frictionless data collection tools

• Collects and ingests personally identifiable information via paper, eConsent, or Registry routes
• Reduces data collection burden on patients and study sites

On-Demand Trial Linkage to RWD Offers flexibility in linkage approach and supports various RWD sources

• Supports a wide range of RWD sources and tokenization vendors
• Enables linkage through de-identified (tokens) or identified (patient identifier) based workflows

Compliant, Up-to-date Data Ensures robust management of clinical trial data linkage consent status

• Meets IRB and GCP requirements
• Supports consent withdrawal even after trial conclusion

Site Enablement Provides comprehensive support for seamless implementation

• Offers training materials to sites
• Enables integration within existing site workflows for out-of-the-box launch

Benefits

Enhanced Evidence Generation Expands insights beyond traditional clinical trials

• Facilitates long-term follow-up studies without additional patient or site burden
• Enables label expansion studies using additional patient variables and outcomes

Improved Trial Outcomes Mitigates challenges in clinical trials

• Reduces impact of loss to follow-up on trial endpoints
• Improves confidence in external control arms through RWD analysis

Economic Value Demonstration Supports discussions with payors and providers

• Measures cost of care and healthcare resource utilization before, during, and after trials
• Provides comprehensive data for economic value assessments