REAL WORLD EVIDENCE

Exon Sciences has great expertise in Real World Evidence (RWE) as mentioned below. To every product development, Real World Evidence is highly being recognized as a necessary tool which provides a robust and cost effective elements.

Companies in life sciences are welcoming the new strategies, technologies and partnerships in the application of RWE, hence they can achieve fresh opportunities to discover, optimize and demonstrate value during traditional & early phase of research.

Strategy & Planning of RWE
Exon Sciences expertise can help guide your strategy and develop the most cost effective path towards your product approval and reimbursement across global markets.
The outcome measures and patient populations require close collaboration with hospitals, providers and patient advocacy groups. Our experience has shown this to be the most efficient way to define optimal inclusion & exclusion criteria and if a study is to be delivered rapidly and with minimal protocol amendments.

PASS (Post-Approval Safety Studies)
Today, there is an increasing trend for regulatory authorities to allow products onto the market with the caveat of a mandated Post-Approval Safety Study (PASS). These studies have specific approval, design and reporting parameters that must be adhered to. However, proactively conducting a voluntary PASS study can avoid some of the more rigid requirements that a regulator might impose. As a result the voluntary PASS is becoming an important part of risk management plans.