EU CTRへの対応はお済みですか?

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.

弊社ウェビナーを視聴

Are You Ready for EU CTR?

The Challenges, Lessons Learned and Innovations Surrounding the New Regulation

 

今すぐ視聴

 

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

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

 

チームへのお問い合わせ

 

CLINICAL TRIAL READINESS

 

 

 

OUTSOURCED CLINICAL TRIAL DELIVERY

 

 

 

DOCUMENT TRANSPARENCY

 

 

 

 

 

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