Bieberer Str. 211 B
D-63071 Offenbach am Main
Phone +49 69 80 10 81 33
Fax +49 69 80 10 81 34
News
New address (since September 2019):
Privacy
The European General Data Protection Regulation (GDPR) is in force since May 25, 2018. GDPR will help us all be transparent about where, when and how data is used and who it is communicated to and processed by. We have updated our privacy policy according to these requirements. You will find the details under "PRIVACY".
Medical Device Regulation (MDR)
I have the expertise and qualification for the clinical evaluation of medical devices based on MDR (2017/745) and I am able to support you in this process and your post-marketing-surveillance activities.
Monitoring
Due to our expertise in data management we know the common pitfalls in the collection of clinical data. We have decided now to use this know-how by offering comprehensive monitoring services, too. Our well-trained and experienced staff will monitor any kind of clinical study, just in time, in order to obtain high-quality data for you. And the data cleaning process will be accelerated, too.
Support for IITs
We are providing support for investigator initiated trials (IITs) such as scientific consulting, preparation of study documents, notification of authorities, monitoring, data management, statistical analysis and medical writing. Lack of resources at your site or having an alternative to local facilites may be reasons for considering a reliable and competent external partner. We have a lot of experience in this field and we are prepared to assist you with our scientific services.
Support for HTA submissions
Support on all statistical aspects of statistical analysis required for HTA submissions (e.g. reimbursement dossiers): Network-Meta-Analysis, indirect treatment comparisons, etc.
2012
Planning and analysis of clinical studies with functional food products according to the European Health Claims Guidance.
2010
Our business started on July 1st 1985, twentyfive years ago. We are proud that many of our clients of the “first hour” are still adhering to us and our services til today. Thank you for your trust and confidence. You might be assured that we will do our best to provide the best possible solutions for your needs today and even tomorrow.