The European Union Clinical Trials Regulation (EU CTR) is set to radically change the clinical trial landscape across Europe. The new Clinical Trial Information System (CTIS) officially went live on 31st January 2022, marking the start of a three-year transition period during which time companies must implement updated processes and assess systems to enable compliance and effective interfacing with the CTIS.
The goal of the EU CTR is to create an environment which is favorable for the conduct of clinical trials in the EU, with the highest safety standards for participants and increased transparency of trial information. To support this aim, the regulation has introduced new requirements which sponsor companies must be aware of in order to enable operational readiness in line with the changes mandated by the regulation.
Our integrated EU CTR offering can provide end-to-end support to sponsors irrespective of your readiness. Syneos Health can both support in preparing you to be ready to conduct trials under EU CTR, and support in your ongoing delivery of clinical trials under the EU CTR.
Clinical Trial Readiness
Syneos Health R&D Advisory provide end-to-end support for sponsors on their EU CTR readiness journey
Outsourced Clinical Trial Delivery
Syneos Health Clinical are EU CTR ready to provide end-to-end outsourcing of clinical trials under EU CTR
Clinical Trial Transparency services to support transparency requirements, including redaction of clinical trial data and documents
Subject Matter Expertise (SME) from within Syneos Health, including EMA CTIS Product Leads & CTIS Super Users