Today’s clinical development and regulatory environment requires biopharma companies to be agile and forward thinking in order to continuously optimize their operating models. As a critical part of Syneos Health Consulting, our R&D Advisory Group helps biopharma companies of all sizes focus on designing, planning and implementing large scale organizational changes that address their specific needs.
Our R&D Advisory Group was built from the Syneos Health acquisition of Kinapse, an industry-leading consultancy with deep expertise in R&D organizational, process and technology-enabled transformations. We blend industry-leading consulting expertise with recognized experts across the entire spectrum of research and development. Our delivery teams combine consulting with hands-on subject matter experts to bring deep insights to our R&D advisory services. Our comprehensive approach goes beyond a single asset or portfolio, looking at four major areas of focus — strategy, process, technology and sourcing — to deliver actionable insights and solutions that are transformative to the organization.
Most importantly, we have a firm belief in being a trusted partner to our customers, establishing long-standing relationships with an independent mindset and dedication to developing solutions with only their best interests in mind.
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.
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. Learn more.
Are You Ready for EU CTR? The Challenges, Lessons Learned and Innovations Surrounding the New Regulation
Tuesday, June 14, 2022 | 9am EDT (N. America) / 2pm BST (UK) / 3pm CEST (EU-Central) 60 min
The European Union Clinical Trial Regulation (EU CTR) is the largest change in the EU clinical trial landscape in 20 years. This year marks the beginning of a three-year transition period during which companies need to implement updated processes and assess systems to enable compliance and effective Clinical Trials Information System (CTIS) interfacing. Companies wanting to run future interventional medicinal trials in the EU now more than ever need to ensure that their readiness programs are prioritized.
The following six major changes mandated by CTR are significant and require processes and systems across sponsors and CROs to be adapted to ensure compliance:
- Clinical Trial Application (CTA) submission to all member states is now done through CTIS, with 12-day RFI (request for information) response times and new constraints to submission modifications
- New labelling requirements for IMP (Investigational Medicinal Product)
- Increased transparency requirements that impact disclosure of commercial confidential information and protected personal data
- Increased clinical trial notifications requirements
- New safety reporting requirements and timelines
- CTIS interaction
Join this webinar as EU CTR experts discuss these challenges and the innovative process design, technology and outsourcing solutions available.