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
- Do the studies meet up to
international standards of patient treatment and laboratory
- 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explanations would be outdated by the time we could compile the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