EXPERIENCE AND REFERENCES
Monipol is a CRO conducting its business activity in Europe with offices in Poland and in Germany. We offer a comprehensive range of services including conduct of I to IV phase studies as well as medical device clinical studies and PMS.
We have conducted more than 150 studies since 1995 when we started our business activity, including 46 clinical studies of phase I and 6 medical devices clinical studies.
We started from single-site studies up to 100 sites studies. The number of participants in one study varied from a few participants to over 4000 participants.
45 000 participants were involved in all studies coordinated by monipol.
The vast majority of studies are vaccine, oncological or cardiological studies
Range of indications we have worked for:
Our team has wide experience in work with electronic devices used during study conduct. As early as in 1999 we started to work with e-CFR, whereas using IVRS/IWRS and e -Diaries belong to routine procedures commonly used by us during conduct of clinical trials.
In 2004 our Quality Management System was awarded the ISO certification. It is subject to constant controls and regular recertification. At present we operate according to ISO 9001:2015.
High quality of our services has been checked and approved by a number of GCP audits, systems audits and local and international inspections.
monipol is the initiator and co-founder of Across Alliance (AA), organization of experienced CRO which actively operates in Europe. Our cooperation started in 2005 is based on Project Management System compatible with the ISO 9001 standard.
Thanks to this cooperation we are able to conduct a clinical study almost in any European country.