PHASE I – IV CLINICAL TRIALS
monipol’s offer comprises the full conduct of clinical trials phase I - IV, starting with research protocol writing through statistical analysis to the final report.
We adjust our services to your individual needs.
In order to fulfil our Sponsors geographical requirements, we cooperate with other European CROs through Across Alliance that allows collective coordination of clinical trials on the territory of most European countries based on a certified Quality Management System (ISO).
Specifically, we offer our Sponsors the following services:
- Feasibility assessment for clinical trial conduct.
- Full preparation and conduct of clinical trials in accordance with ICH-GCP rules and current regulation based on Sponsor’s or/and our own Standard Operating Procedures.
- Elaboration and multiplication of study related materials (Study Protocol, CRF, Subject Information, Patient Diary etc.).
- Preparation of relevant documents and study submission to the Bioethics Committee and Competent Authority for Register of Clinical Trials.
- Recruitment of study participants.
- Full standarisation of study conditions in clinical pharmacology studies (regimen, diet, laboratory tests etc.).
- Proper receipt, transport, storage and dispensation of medicinal products.
- Complete Quality Management System.
- Study documentation in traditional and electronic form (Remote Data Entry).
- Biochemical, serological, pharmacokinetic analyses in specialist, certified laboratories
- Statistical analysis and final report.