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.
Are You Ready for EU CTR?
The Challenges, Lessons Learned and Innovations Surrounding the New 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.
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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 |
Document Transparency 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
CLINICAL TRIAL READINESS
OUTSOURCED CLINICAL TRIAL DELIVERY
DOCUMENT TRANSPARENCY
