We support you as your Legal Representative in Europe according to the EU Clinical Trial Regulation 536/2014 and the former EU Clinical Trial Directive 2001/20/EC Art. 19 (1) and in Switzerland following the Clinical Trials Ordinance.
We act as your Data Representative in accordance with the European General Data Protection Regulation (GDPR) EU 2016/679, if you are a non-European company conducting clinical trials in Europe.
Our experts have decades of experience in medical device and pharmaceutical regulatory affairs. We can help you navigate the complex regulations to expedite approvals, reduce costs, and optimise product development.
We implement specific CRO/vendor management oversight and governance strategies and processes to ensure adherence to contract and agreed budget, timelines and quality of your projects.
We provide proactive, risk-based oversight management systems to effectively manage your clinical trial performance, in compliance with relevant ICH-GCP guidelines and ISO standards.
Lumis International – Your clinical gateway to Europe
Lumis International specialises in providing legal representation for clinical trials, for non-European small to mid-sizedbio-pharmaceutical and medical device companies around the globe. We are headquartered in Germany. Find out more
Lumis Life Science Consulting – Your partner for clinical oversight
Our goal is to optimise your drug development process and clinical trials performance using a unique holistic approach from vendor selection to clinical trial oversight management. We act on behalf of our sponsors. Find out more
Contact our experts to find out more!
We look forward to helping you accelerate your clinical development!
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-Transitioning studies approved under the Clinical Trials Directive 2001/20/EC (CTD) to the new Clinical Trials Regulation 536/2014 (CTR) is a common challenge for sponsors. This blog will provide an overview of how to transition a study to the CTR and some key considerations. …
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