The primary goal of an EAP is to provide access to treatment. However, capturing Real World Data (RWD) and generating associated Real World Evidence (RWE) from these programs is becoming increasingly valuable. The collection of RWD can provide vital intelligence, including learning more about patient populations and real-life experiences. Furthermore, the data can be utilized to supplement regulatory or reimbursement activities in line with FDA and EMA directives.
As an established CRO, we have tried and tested processes alongside an industry-leading platform for data collection, which provides real-time reports and is 21CFR Part 11 compliant. As such, Bionical Emas can deliver all aspects of Real World Data collection, evidence generation and application with quality and precision.
Our dedicated EAP Real World Data Managers can share insights and provide advice to support all key functions within your organization to develop an effective and compliant RWE strategy.