
Case
Integrating Real-World Evidence for Market Success
How InnoStrat Enabled a Rare Disease Pharma Company to Build a Unified Evidence Base for Launch
The challenge
A medium-sized pharmaceutical company specializing in rare diseases sought to enhance its upcoming treatment launch by integrating real-world evidence (RWE) with clinical trial data.
The objectives were to:
- Develop a comprehensive evidence base supporting regulatory approval and market access.
- Implement a structured approach to collect, process, and utilize RWE effectively.
- Align internal teams on the strategic value of RWE in supporting the product’s market success.
Our approach
InnoStrat collaborated closely with the client to achieve these goals through the following steps:
Advanced IT Framework Implementation
We introduced a robust IT infrastructure capable of seamlessly processing and integrating RWE from various platforms. This system ensured data consistency, quality, and accessibility across departments.
Expert Training and Strategic Alignment
Our team conducted specialized training sessions for key stakeholders, emphasizing the importance of RWE in the product lifecycle. We facilitated workshops to align clinical, medical, and commercial teams on the strategic utilization of RWE.
Integrated Clinical and RWE Study Program Development
We assisted in designing a cohesive study program that combined clinical trial data with real-world insights. This integrated approach provided a holistic view of the treatment’s effectiveness and safety in diverse patient populations.
The result

Successful implementation of an advanced IT system for RWE integration.

Enhanced cross-functional understanding and utilization of RWE.

Establishment of a comprehensive evidence base supporting regulatory and market objectives.

Strengthened positioning of the new treatment in the rare disease market.
What this means for you
Integrating RWE with clinical data is pivotal for demonstrating a treatment’s real-world impact, especially in rare disease markets.
InnoStrat’s approach ensures that pharmaceutical companies can harness the full potential of RWE, leading to informed decision-making and successful product launches.