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

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

Key Performance Indicators for effective Clinical Trial Oversight Management Read More

Sponsor-vendor relationship – it takes two to tango (at least) CRO Management
- The number of small Biopharmaceutical and Medical Device Companies (“small sponsor companies”) conducting early stage clinical trials is increasing. Outsourcing and vendor management are essential for survival of these companies, since they are usually facing the challenges of limited budgets and resources.

Sponsor-vendor relationship – it takes two to tango (at least) Read More

Are you ready to outsource your clinical trial? Outsourcing in Clinical Trials
- Outsourcing of clinical research to a CRO or other vendors is a critical business process with a high impact on the outsourcing company and its procedures, especially for small sponsor companies.

Are you ready to outsource your clinical trial? Read More