欧州での臨床試験の状況を一変させるために、EU臨床試験規則（EU CTR）が策定されました。2022年1月31日に、新しい臨床試験情報システム（CTIS）が発効し、3年間の移行期間が始まりました。その間、企業は更新版のプロセスを実施し、コンプライアンスと、CTISとの効果的なやり取りができるかどうか、システムの評価を行わなければなりません。
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
