Anticipate and manage changing enrollment environments

With the adoption of the EU Clinical Trials Regulation (Regulation EU No 536/2014) and a single submission, clinical trial sponsors face the challenge of rethinking the way we approach patient recruitment planning and execution for trials conducted in the EU.

BBK can help you navigate the new requirements, including having to submit recruitment plans as part of the upfront submission — and the timelines for doing so.

The Immediate Impact of Regulation (EU) No 536/2014 on Patient Recruitment

Rob Laurens
Chief Patient and Provider Officer

Regulation (EU) No 536/2014 replaces the Clinical Trials Directive 2001 / 20 / EC and looks to ensure a unified set of rules for the conduct of clinical trials throughout the European Union. From the outset, policymakers had the aim of making the EU more attractive to clinical trials by simplifying submissions, authorizations and conduct among EU member states, thereby also offering greater transparency into trial data.

How can we help you today?