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Early Access Programs

Real World

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.

Case studies.

Global EAP for a specialised Biotech company Play Video
European EAP with tailored RWD strategy Play Video
Global early access program takeover Play Video

How can we support you?

If you are a Healthcare Professional seeking access to a Bionical Emas EAP product

COVID-19 Guidance & Measures

A statement from the Bionical Emas Group on guidance & measures regarding COVID-19 - read here

In relation to staff and visitor safety, we have full risk assessments in place for all of our workplaces. These risk assessments are revisited and updated regularly, to reflect changing risks, knowledge and circumstances, and to reflect evolving Government guidance. We have not placed the risk assessments here on the website as they would become out of date too quickly. However, you are welcome to email info@bionical-emas.com to request access to our most up to date risk assessments applicable to your needs. Please note that all our staff are notified of all applicable risk assessments and updates, along with ‘quick guides’ automatically via our e-learning system.