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The EU Clinical Trial Regulation (CTR) will introduce a new Clinical Trial Information System (CTIS) that provides a collaborative platform for Sponsors and Regulators to manage trials across the EU. It promotes patient safety, supporting cross border trials and increased transparency. Sponsors will be required to undertake organisational transformation to ensure compliance with CTR.
We have been supporting CTR/CTIS projects since its inception, where we supported EMA to current day and where we are supporting multiple clients prepare for the implementation of CTR.
*Estimated timelines calculated by applying time periods of EMA last published timelines against current publicly available state of CTIS.
The first milestone for CTIS will be in early 2022. Are you ready? If not, you’re not alone. And we are here to help.
Deloitte NL’s long term investment in CTIS and trusted approach to structured data, we bring you a combined approach to help you get ready.
To start you off, we hosted the Webinar “CTIS: ready or not, here it comes” Please register to download the webinar
What can you expect?
- What is really new in CTIS and what stays the same compared to CTD
- Where are we on the timeline and how you can situate your company on it
- What are some of the pitfalls with regard to CTIS readiness and how to solve them
- Approaches to organisational readiness
- Approaches to procedural readiness
- The opportunity to raise questions
What should you do to prepare for CTIS:
- Start a CTIS readiness project as soon as possible!
- Raise CTIS awareness in your organisation
- Assess the state of your CT data sources
- Implement CTIS in your Clinical Operations processes
- Build CTIS ready technical solutions
Sebastian is a Director at Deloitte and a Life Science specialists and focusing in Life Science Risk Advisory with over 20 years of experience in consultancy. Assisting organisations with insight and strategy delivery, in the face of significant Life Science regulatory and technological change. Since June 2014 the lead for the Deloitte’s Business Services collaboration with the European Medicines Agency and has overseen a number of Deloitte supported projects at the Agency. The leader of Deloitte CORE (Centre of Regulatory Excellence for Life Science) from 2016-2020, A global initiative, which supports Life Science companies implement systems and processes for current and emerging Life Science regulation.
Duncan van Rijsbergen
Your second host is Duncan van Rijsbergen. For over 13 years Duncan was active as an RA professional in top 20 pharma companies. He carried RA responsibility for major products dealing with CMC, clinical, product information, safety and administrative aspects. Since 2016 applies his RA knowledge in pharma and RA data projects with Iperion – a Deloitte business, with a special interest in cross-functional data flow. He is also experienced in CTIS (CTR) data mapping including analysis, business case development and solution design for E2E change control. He also pursues a degree in Computer Science.