PharmaBoardroom

Company description

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.

Products and services

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