MEDICAL SERVICES
Drug development process is not just a sequence of single clinical trials. The key factor of success in clinical research is maintaining long-term and day-to-day working communication with the most competent professionals and opinion leaders in different areas of medicine.
LEGE ARTIS implemented institution of Medical Advisers - managers of the Medical department with an overall responsibility for a therapeutic area (i.e. oncology, cardiovascular disorders, neurology etc.). Medical Advisers work in close contact with the Clinical and Regulatory Affairs departments.
Being medical doctors (usually with a PhD degree in medicine) and specialists in different therapeutic areas, having many-years scientific research and/or university lecturer experience, and working at CROs for several years, Medical Advisers bring clinical practice and research expertise together.
In order to assist Clinical Trial Sponsors in execution of the ICH-GCP requirements and US, European and local regulations with regard to the medical aspect of clinical trial processes, procedures and documentation, trial-related medical decisions, and medical care of trial subjects, LEGE ARTIS offers several services:
- Medical review of clinical trial documentation;
- Feasibility Studies conduct;
- Medical documentation writing;
- Medical monitoring.
Working as partners, Clinical Trials Sponsor, LEGE ARTIS medical personnel and investigators can guarantee the highest quality of the data and processes in a clinical trial.
