Real World Data

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Building a comprehensive understanding of a medicine goes beyond clinical trials.

Collecting Real World Data (RWD) within a Managed Access Program is a critical opportunity, especially when dealing with unlicensed medicines.

Here’s why:

1. First Real-World Observations: Unlicensed medicines often lack extensive real-world data. Managed Access Programs often provide the first opportunity to observe how these medicines perform outside of controlled clinical trials. This early exposure helps uncover valuable insights.
2. Safety and Efficacy: RWD collected during early access allows us to monitor safety and efficacy in diverse patient populations. It helps identify any unexpected adverse effects or benefits.
3. Optimizing Usage: Understanding how healthcare professionals and patients use the medicine informs optimal dosing, administration, and patient management.
4. Demonstrating Value: RWD helps identify what data best demonstrates a medicine’s value. It provides insights into patient outcomes, safety, and effectiveness beyond the controlled setting of clinical trials.
5. Reimbursement and Market Strategy: Companies need evidence to drive reimbursement decisions and market launch strategies. RWD informs pricing, access, and market positioning.

Here’s how Clinigen supports RWD collection:

• Light-Touch Data Collection: Clinigen’s online platform simplifies data contribution for physicians and patients. It supplements Health Economics and Outcomes Research, market access strategies, and reimbursement efforts.
• Data Analytics: Clinigen’s skilled data analytics team provides meaningful analysis and custom reports at key program stages. This ensures informed decision-making.

The result? Medicines are used optimally, regulatory approvals are timely, and pricing aligns with value.