European experts in
conducting global clinical trials
European experts in
conducting global clinical trials
Who we are
Human. Experienced. Independent. Since 1993.
We are your partner for clinical studies, with peerless-quality consulting and support through practice – because the comprehensive know-how behind intelligent study design, perfect planning and systematic implementation is just the visible part of a successful clinical study. Others can do that too.
What makes us unique is the human component: our know-who: Not only do we know the most suitable research institutions for your clinical study, we also know the responsible study teams personally. We understand clinical practice, and we know who and what is required to carry it out. We have years of experience in dealing with ethics commissions and other authorities, and we see ourselves as bridge builders between interests.
In short: we never lose sight of the people behind the clinical study – be it the participating patients, the employees in the clinics conducting it or you as the client.
Outstanding performance deserves the swiftest and best support. This applies in particular to medical advances.
On your way to market success, rely on the comprehensive KNOW-HOW and KNOW-WHO of E&E CRO Consulting: the European experts reliably deliver valid results and data, saving you time and money.
The E&E CRO Consulting Team
Michael Freigassner has a background in intensive care practice, and, thanks to his years of experience in the medical technology industry, he understands the sector’s needs and expectations. His broad expertise has added to E&E CRO Consulting’s wealth of experience, and he manages E&E CRO Consulting operatively in close cooperation with its founder.
Founder & CEO
After decades of hospital work and a wealth of personal experience in conducting clinical studies, Ilse Eder switched sides. Because: “There must be a better way”. And there is. With her expertise, her experience, her gift for clear communication and her ability to get everyone in the same boat, she has built E&E CRO Consulting into the largest “small” player for clinical trials.
Back Office Manager
Lisa Reiffenstuhl has supported numerous projects as study administrator, and our team as office manager, for several years. Thanks to her extremely precise working methods, her contribution is integral to the success of our projects. As team leader, she is the one who keeps track of everything and pulls all the strings together.
In addition to the core team, E&E CRO Consulting also has an experienced international network of highly qualified medical professionals – so you always have a contact person on site!
What we stand for
For us, people must always be the focus. That’s why we are one of the few providers to offer on-site case support for clinical trials in the study centres.
In order to meet our standards, constant quality control is essential. It goes without saying that we work according to current GCP, ICH EN ISO 14155 and FDA guidelines. Our employees regularly participate in further training courses and seminars. Furthermore, we have ourselves audited and re-certified annually by international experts.
We consider ourselves responsible above all to the patients who make themselves available for medical studies, so that at the end of our work usable conclusions and valid data result.
Who we work for
Start-ups, internationally established companies and innovative minds
We are THE partner for anyone who wants to put the clinical trials of their ideas in truly experienced hands:
- You work as a start-up or you’re part of a bigger player in the medicine market?
- You have an idea for an innovative medical product?
- You’re about to test your idea/product in practice?
- You need a reliable and experienced partner for the clinical study?
- You need contacts to test centres?
- You’re looking for sponsors for the clinical testing and the development of your product for the market?
- You’re unsure about submissions to health authorities?
- You’re looking for THE trustworthy contact partner to accompany your idea to market readiness?
With us you’ve found the right partner for every phase of your product development.
Still not sure if we meet your requirements?
We would be happy to take the time to talk to you personally and to compile a list of references from your specialist area.
Where we come from
Foundation of Euromed GmbH: E&E CRO Consulting is established as a department of Euromed
Foundation of Eder&Eder GmbH: takeover of E&E CRO Consulting
Foundation of HSEC – Health Service and Education GmbH: takeover of E&E CRO Consulting
E&E CRO Consulting founded as a separate company
DIN EN ISO 9001 certification by the German ESC Cert GmbH
E&E CRO Consulting becomes an independent sub-company under the umbrella of our partner Principal Technologies Inc.
What we offer
Faster, more established and better-connected to market maturity
Experience and honesty are the cornerstones of our service. Since 1993, E&E CRO Consulting has been supervising clinical studies of all kinds – so we have more than enough experience to be able to offer you honest advice. You will always receive genuine feedback and transparent service from us: Can your idea be implemented in practice? Where do we see possible problems with approval or market launch? Why do we recommend a particular study centre? Who could be a possible partner for you? Why are we choosing a particular study design?
- Decades of experience
- Personal service
- Comprehensive overview of the medical product market
- Global selection of participating research institutions
- Extensive expert know-how in study design
- CASE SUPPORT on site
- No loss of capacity and resources
E&E CRO Consulting guarantees you complete service for clinical studies – and by “complete” we mean absolutely everything:
- Project preparation
- Advice on the selection of suitable study centres
- Advice on the creation and review of study-specific documents
- Submissions to health authorities and ethics commissions
- Document and data management: revisions, modifications
- Supervision of study centres: contract management, recruitment support, logistics of study materials & device accountability
- CASE SUPPORT: presence during the treatment of study patients, with the test product, on site and in compliance with the test plan
- “First-in-human” studies
- Product training and monitoring on site
- Support in the selection of external service providers
- Quality assurance in compliance with current GCP, ICH EN ISO 14155 and FDA guidelines
- Personal support over the entire course of the study
- Honest feedback
- Access to a large international network (clinics, sponsors, partners etc.)
Still want more?
We would be happy to send you our catalogue with additional services. Don’t need everything? Of course you can also make use of only a selection of our services.
Just contact us!
It’s a long road from innovative development to market maturity, but this road can be significantly shortened by the choice of the right CRO partner. E&E CRO Consulting is that partner: the European experts in a field that is strongly characterised by know-how, and even more by know-who.
Stable. International. Connected.
As an autonomous entity under the umbrella of Principal Technologies Inc, we have both the independence and the financial stability to guarantee the longevity of our services. This enables us to be present in the market as a relatively small player, to grow in a controlled manner and to expand our network independently.
Our diverse partners include universities of medicine, other international CROs, as well as start-ups in the pharmaceutical/medical sector worldwide and international pharmaceutical/medical technology companies.
TAKE HOME Message
Studies alone don’t bring market success: The professional team at E&E CRO Consulting supports you on your way to a clinical breakthrough with a complete service package, and takes care of ALL the necessary practical steps.
Always within the limits of what can be done. By your side at all times.