Understanding the European Union Clinical Trial Regulation 536/2014 (EU-CTR)
新たなEU-CTRは、臨床試験の効率化を促進し、患者と研究者の双方にとって多くの利点をもたらす一方で、スポンサー企業にとっては、新しい規則への対応に課題も伴います。Certara’s depth of expertise and full suite of transparency and disclosure services allow us to help clients successfully navigate this new regulatory territory.
Download this white paper and learn the goals of the new EU Clinical Trial Regulation, along with key timelines and best practices you need to know for a successful submission.
Download our white paper to explore:
- The goals and key implications of the new EU-CTR for those conducting clinical trials in Europe
- A comprehensive understanding of the updated Clinical Trials Information System (CTIS)
- Compliance strategies to meet the CTIS transition timelines
- Guidelines for anonymizing and redacting clinical trial data
- Proven tips for enhancing recruitment and retention of clinical trial participants
- Best practices for preparing Plain Language Summaries within the new submission timelines
Simply fill out the form and download the white paper for free!
