Phase I – IV clinical trials
As part of its services, Monipol International conducts clinical trials of drugs and medical devices in a comprehensive manner. Our activities range from phases I to IV, from the creation of the clinical trial protocol, through statistical analysis, to the preparation of the final report.
Each order is approached individually, adjusting our services to the needs of our Sponsors. We co-operate with other European CROs associated in the Across Alliance, an organisation created on our initiative. Together we coordinate clinical trials in many European countries based on the guidelines set out by Good Clinical Practice and Quality Assurance.
Scope of services provided by Monipol International:
- we analyse possibility of clinical trial conduct (Feasibility),
- we prepare relevant study documentation and submit it to the Bioethics Committee of a given country and to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products or BfArM in order to register and obtain approval for clinical trial conduct,
- we offer comprehensive preparation and conduct of a clinical trial in accordance with the principles of Good Clinical Practice (ICH-GCP) and the legal provisions of Polish and German legislation. We operate on the basis of the Sponsor’s Standard Operating Procedures (SOP) or/and our own. In clinical pharmacology studies we ensure full standardisation of study conditions (lifestyle, diet, laboratory tests),
- we ensure recruitment of study participants by study sites selected in the Feasibility phase,
- we draw up, prepare and copy materials related to the study (protocol, CRF, patient information, patient diaries, etc.)
- we provide biochemical, serological and pharmacokinetic analyses in specialist laboratories (with certified quality control),
- we ensure a full Quality Assurance system for ongoing clinical trials,
- we ensure professional handling of receipt, transport, storage and release of tested product,
- we prepare statistical analysis and final report.