I was trained at the University of Ulm, Germany in Physics (academic degree: Graduate Physicist (Dipl. Phys.)) with specialized area biophysics. I was also trained in medicine (academic degree: Medical Doctor (Dr. med.)).
From 1985 to 1992 I was in leading positions for clinical research in middle size national and globally active pharmaceutical companies. Last position was Deputy Director of the Clinical Research Institute of SmithKline-Beecham in Neuss, Germany. During this period, I was member of international working groups being involved in all phases of clinical drug development (phase I, II, III and IV).
Since 1993, I am an entrepreneur. I was Founder, CEO and Medical Director of PharmPlanNet Contract Research GmbH at Mönchengladbach, Germany from 1993 – 2005. In 1999 I started first activities in Chernivtsi Ukraine in cooperation with local business partners and the Bukovina Medical Academy. In 2003 I was Founder of PharmPlanNet Ukraine Clinic Ltd in Chernivtsi, Ukraine and CEO until 2004 and I am still major shareholder of this company which was renamed to INNOPHAR – Ukraine Innovative Pharma Research Clinic Ltd in 2005.
I started clinical research activities in 2005 in the Republic of Moldova, supported by the Ukrainian company, and was Founder and CEO of INNOPHAR MO SRL from 2009 – 2013 in Chisinau, Republic of Moldova. Since 2015 I am independent Consultant for Clinical Research and head of CRFF-Solutions.
I gained experience in clinical research, especially in the early phases of clinical drug development (phase I and IIa), in more than 35 years. As investigator, sub-investigator or clinical project manager in over 300 clinical studies, I am familiar with the special requirements of phase I to III clinical studies getting reputation as a rescue site provider, proven in several multicenter clinical trials of phase II and III in Chisinau, Moldova. I worked in pharmaceutical Industry as well as in the CRO business. Therefore, I am well aware of the areas of conflict which have to be balanced between sponsors, CROs, clinical sites and trial participants in clinical studies.
During my physical training I realized the importance of “boundary conditions” in scientific experiments especially in biological systems. When I started to take over responsibility for clinical research projects in pharmaceutical industry I tried to transfer my experience in “boundary conditions” into standards for the conduction of clinical studies to increase the quality and validity of clinical data (including PK data) obtained in clinical studies. Especially in the early phase of clinical drug development (phases I and IIa), where low sample sizes are the rule in clinical studies, clinical data validity is the basis for making the right decisions for successful drug development.
My expertise in clinical research is also documented in 40 publications (*).
As Consultant Clinical Research, I am consulting mainly middle sized CROs, SMOs, pharmaceutical and biotech companies in clinical drug development. In addition, I offer training for investigators, study nurses, monitors, clinical site managers and project managers.
I am looking to connect with deciders preferably in middle-sized pharmaceutical and biotech companies for outsourcing of clinical drug development projects.