Our Services

Legal representation

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.

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Data representation

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.

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Regulatory Services

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.

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CRO/Vendor Management

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.

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Oversight Management

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.

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Lumis International

Lumis International – Your clinical gateway to Europe

Lumis International specialises in providing legal representation for clinical trials, for non-European small to mid-sized bio-pharmaceutical and medical device companies around the globe. We are headquartered in Germany. Find out more

Lumis_Consulting

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!


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    We look forward to helping you accelerate your clinical development!

    Heike Schön

    Managing Director

    Phone: +49 30 235911-599

    info@lumisinternational.com

    We look forward to helping you find your best fit in outsourcing your clinical trials!

    The latest from Lumis’ Content Hub

    Medical device clinical trials - regulatory pathways
    Regulatory Pathways for Medical Device Clinical Trials News
    Medical device clinical trials - regulatory pathways
    - This is a comprehensive review of the process, pitfalls, and procedures to get study approval for medical device clinical trials. We look into the future and unpack the present, in terms of European medical device regulation and the local regulatory landscape. Along with the intricacies of EU MDR 2017/745 medical device regulations, we provide an important summary of medical device study classifications and the corresponding submission pathways.  …

    Regulatory Pathways for Medical Device Clinical Trials Read More

    Transitioning to the new Clinical Trials Regulation (CTR)
    Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations News
    Transitioning to the new Clinical Trials Regulation (CTR)
    - 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. …

    Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations Read More

    Clinical trials of medical cannabis
    Medical Cannabis Clinical Trials Clinical Trial Oversight Management
    Clinical trials of medical cannabis
    - Medical cannabis research is evolving rapidly. In this article we examine the recent developments and challenges faced, focusing mainly on Europe and the US. …

    Medical Cannabis Clinical Trials Read More

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