One of the main specialization of our company is to organize, conduct, monitoring and enforcement of the various studies in the pharmaceutical field – pre-clinical studies,clinical trials of all phases, including bioequivalence studies and postmarketing observational studies. We provide a service, "a study on the turnkey" - we take on the entire process, from the preparation of documentation and to write a report on the study, and individual service that your company needs. Our company has professionals with extensive experience in the development of documentation, for example as the study protocol for the proper and effective conduct of the clinical study. Those carrying out the monitoring of clinical trials in our company are properly trained and have not only the experience but the qualifications and certificates.
We offer you the services for organization and conduct of studies. We provide a complete provision of the whole process (the “turnkey study”), and separate the fragments of interest to you, such as:
Development of the study Protocol
Preparation of the accompanying documentation (Case Report Form, the researcher’s brochure, informed consent of the patient)
Selection of a clinical base for the study
Conduct of monitoring and audit visits to the clinical base
Organization of the insurance of volunteers participating in the bioequivalence study
Representation of the interests of your company in the authorized state regulator, etc.