Dear colleagues,

 


more and more inquiries are being made about Contract Research Organisations (CRO) and the feasibility of various studies in Eastern Europe, more specifically about the infrastructure, logistics, and cultural conditions in the various Eastern European countries.


Questions such as:

  • Has approval been given by BfARM or FDA for studies and data compiled and completed in the East?
  • Have audits (in particular FDA audits) showing successful results been made Eastern European centres/countries?
  • Do the studies meet up to international standards of patient treatment and laboratory diagnoses?
  • Are there specialized CRO's across numerous Eastern European cities capable of successfully carrying out multinational multi-centre studies?
  • How is the quality of the data in Eastern European centres guaranteed?
  • What criteria are decisive in the choice of specialized CRO and Eastern European country, and many others reach us almost daily?


"S&P" Pharmatest, in cooperation with our sponsors, has been working for more than half a decade as a specialist in Eastern European clinical studies. The growing trust of our sponsors is an expression, and proof, of the ability to undertake successful studies (in the most varied indications) in pivotal Eastern European countries such as Bulgaria, Russia and the Ukraine, Poland, as well as the Czech and Baltic Republics.

The result of comprehensively answering all of the questions asked us would probably be a textbook with hundreds of pages. Many of these explanations would be outdated by the time we could compile the information in such a format, and so we have decided to regularly produce a newsletter which will at least partially answer some of the most pressing and frequently asked questions, often expressing insecurity based on lack of information. Leading experts in the field, with whom we have worked for years, will keep you informed with important and interesting facts from their area of expertise. Many questions from our U.S., European and Japanese partners have recently concentrated on Hepatitis and HIV, for which reason we will deal with these topics first. To give you an opportunity to find particular topics which are of interest to you in this newsletter, we ask that you please share your questions and opinions, as well as your criticisms, with us. Needless to say, any correspondence with us will be held in strict confidentiality unless specifically stated otherwise.

Parallel to the publication of the "S&P" News is the availability of our information brochure, Approval Processes in Eastern Europe. If you are interested in this topic, please let us know and we will be more than happy to provide you with a complimentary copy.

In anticipation of your feedback,

Dr. Alexander Siebel