We provide targeted suport services, in different range and phase, of research or scientific programmes and clinical trials of medical products or devices accord to principles of GCP (Good Clinical Practice) and existing law.
- Administration and monitoring of clinical trials for medical products according to GCP (Good Clinical Practice) and research for medical devices
- Comprehensive analysis of research feasibility and management of all their stages
- Preparation of trial site’s documentation to audit
- Writing statistical designs (statistical analysis), creating statistical and final report
- Professional training for clinical research associates and study teams
- Preparation of complete documentation which is essential to submission a clinical trials for medical products and to registration of medical products in Ethic Committee and in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
- Comprehensive clinical trials monitoring from II – IV phase connected with caring for Site Trials
- Choice of potential Site Trials for particular clinical trials (preparation and training study team before trial begins, creating a report about state of research in particular trial sites, closing study sites and creating final report)
- Involved and experienced team guarantees efficient service of projects and optimalization of cooperation effects.