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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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!

    We invite you to book a 15 minute conversation with Heike Schön to discuss your clinical project. Book here.

    Your data will be stored to provide you with information on our services and products. You may unsubscribe at any time. Please refer to our privacy policy for more information on how we store your data and how to unsubscribe.

    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

    Half of wooden peg set OK, other half falling representing the failure of a clinical trial
    Rescue clinical trials – how to avoid the failure of clinical trials Clinical Trial Oversight Management
    Half of wooden peg set OK, other half falling representing the failure of a clinical trial
    - Considering the already high costs involved in conducting clinical trials, the complex regulatory environment, expectations of investors and other stakeholders, the lack of early warning systems of potential clinical trail failures is surprising. In this article we discuss possible reasons for failure and how to better manage these trials.

    Rescue clinical trials – how to avoid the failure of clinical trials Read More

    Risk Based CRO Management is a juggling act
    Risk-based CRO management made easy CRO Management
    Risk Based CRO Management is a juggling act
    - Following the implementation of the new medical device regulations and the revised ISO 14155:2020, the planning and implementation of clinical investigations are a major challenge, especially for small and midsize medical device enterprises (sponsors). Here we walk through how to make the process easier.

    Risk-based CRO management made easy Read More

    Participants in a decentralised clinical trial
    Decentralised Clinical trials – oversight and vendor management Clinical Trial Oversight Management
    Participants in a decentralised clinical trial
    - The concepts around decentralised or virtual clinical trials have been extensively developed over the last years. Especially with the start of the COVID-19 pandemic, companies have been faced with new challenges: to keep the patients in their ongoing clinical trials or even to recruit new patients for the studies. Regulatory authorities adjusted quickly to support new approaches to clinical trials and the concepts of decentralised clinical trials experienced a large upswing.

    Decentralised Clinical trials – oversight and vendor management Read More

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