Our Services

Legal Representation

We support you as your Legal Representative in Europe according to the 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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Outsourcing Clinical Trials

Tailored to your specific needs and expectations, we provide individually adjusted CRO and vendor selection processes to ensure a successful cooperation with your partners.

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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

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    Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations News
    - 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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    Key Performance Indicators for effective Clinical Trial Oversight Management Clinical Trial Oversight Management
    - Most companies outsource their clinical trial activities, however it is the sponsor who is entirely responsible for the clinical trial performance. Without mirroring the work of the CRO

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