Interview with Jacek Barlinski, Country Manager, Nycomed Poland
As we are just starting 2011, could you share with us the results of Nycomed Poland in 2010? In 2010, the affiliate has not been as successful as the previous…
Address: ul. Długa 31/3 31-147 Kraków,Poland
Tel: +48 12 630 18 50
Monipol is a Contract Research Organisation (CRO) and was founded in 1995. We believe that our strength lies in our experience, our readiness to adapt to our sponsors’ needs and our highly trained staff.
Monipol’s founders and managing directors are Dr med. Jarosław Stępień, and Dr rer. nat. Raphael Teichmann.
Dr Stępień was born and grew up in Poland where he studied medicine in Cracow.
Dr Teichmann, who was also born in Poland grew up in Germany and studied biology in Cologne and Düsseldorf.
Both directors worked for several years in clinical research for an international pharmaceutical company and conducted several clinical trials in Poland in the early 1990s. Their outstanding experience with Polish investigators and their patients led them to establish a Contract Research Institute to conduct clinical trials in Poland.
Monipol’s Polish office opened in Kraków in 1997 and in 2002 a new and modern 24-bed Phase I Unit was built in Kraków – Nowa Huta.
In 2004, monipol’s Quality Management System was awarded a DIN EN ISO 9001: 2000 norms certification by the TŰV CERT certification body. The following components were certified:
– Investigational site selection including medical, regulatory and GCP aspects,
– Planning, conduct and supervision (Project Management) of clinical trials Phase I,IV
– Management of investigational site ( Hospital, Centre for Clinical Pharmacology Research),
– Conduct of external audits.
During the scheduled 2007 recertification audit TŰV CERT certified monipol’s Quality Management System for three successive years.
Monipol’s offer comprises full or partial conduct of clinical trials phase I-IV. We can offer you the following services:
Initial assessment of your individual needs and the possibilities for conducting your clinical trial.
Thorough preparation of protocol and CRFs and all necessary formalities
Translation of patient documentation into English, Polish, German, Ukraine, Russian
Site selection and investigators’ recruitment
Organisation of investigators’ meetings
Preparation of documentation for Bioethics Committees
Registration of trials with the local Competent Authorities (e.g., CEBK/Poland, BfArM or PEI/ Germany, Pharm Centre/Ukraine).
Clinical trial monitoring conducted by local monitors with a good command in English
Storage and distribution of medication controlled by a pharmacist
Data flow and statistical analysis
Clinical trial report
Central diagnostic analysis of samples at certified laboratory
Phase I clinical trials in our 24-bed site in Kraków
Bioequivalence trials
Investigational site audits (in Poland as well as in other countries)
Quality management
Trial documentation archiving
Good Clinical Practice (GCP) training for monitors, investigators, research staff, pharmaceutical staff and members of Bioethics Committees
As we are just starting 2011, could you share with us the results of Nycomed Poland in 2010? In 2010, the affiliate has not been as successful as the previous…
When we look at the full year 2010 unaudited IFRS consolidated sales, we see that Ipsen performed very well in 2010 in Central and Eastern Europe. How has Poland alone…
You joined Eli Lilly Poland in November 2008 as a Marketing Director and you have been leading the affiliate since January 2010. Moreover you are co-chairing the LAWG – Local…
The pharmaceutical industry market growth, including generics and originator drugs, is today steady and sustainable, approximating 10% year on year. The market size is over five billion Euros which makes…
In the pharma world, managers change frequently from one company to another, and this phenomenon has been accelerated with the consolidation of the market, however you chose to dedicate your…
Polski Holding Farmaceutyczny (PHF) was put together in 2004 as a capital group consisting of three leading Polish pharma producers and the mission given by the State Treasury Minister was…
For years Polpharma has been the market leader in Poland. In many countries the arrival of multinational companies (MNCs) led to the loss of leadership by the historical players to…
Unlike many pharmaceutical companies, Servier fully operates in all pharma business activities in Poland: research, drug manufacturing and distribution, and health education. Considering your extensive international and regional experience in…
With the current acquisition of Genzyme by Sanofi-Aventis, the French giant is planning to have Genzyme as a centre of excellence for rare diseases. Genzyme operates in the genetic market,…
Until very recently originator drugs had a very weak presence in central and east European countries including Poland, and there was no real patent legislation. Nevertheless, Poland has changed and…
The group has significantly invested in Poland. Are you today generally satisfied with the initial and follow up investments from Mediq in the country? The group has been present in…
Stretching across the heart of continental Europe, Poland is a massive bridge that links east and west, old and new, and which epitomizes a changing continent. At one time…
See our Cookie Privacy Policy Here