Professional team of physicians and medical nurses having a great experience in clinical studies including early phase trials and bioequivalence studies, works in the clinic.
The study team has a great experience of research work, valid GCP certificates which ensures conduct of trials in full compliance with regulatory requirements and study standards: ICH GCP (Good Clinical Practice), national standard of the Russian Federation GOST R 52379-2005.
To perform certain projects, the clinic can engage principal investigators and specialists from other academic and research medical institutions.
On the base of “Certa Clinic” LLC, phase I-IV trials including bioequivalence studies can be carried out.
Professional physicians, full-time medical nurses experienced adequately in clinical studies work in the clinic. The team is experienced in work with various electronic data recording systems, electronic and paper CRF and diaries.
The team of “Certa Clinic” LLC has experience in clinical studies of over 20 years. Study investigators have taken part in clinical studies in therapy, cardiology, pulmonology, gastroenterology, endocrinology, acute upper respiratory infectious diseases, viral infections, etc., as well in bioequivalence studies. The study team includes therapists, clinical pharmacologists, cardiologists, endocrinologists, pulmonologists.
Presence of own database of patients and volunteers, work with referrals ensure good quality and timely enrollment of participants, as well the personnel work timely planned to the start of a clinical study (preparation and harmonization of source document templates, pre-screening) give possibility to start a study as soon as possible.
Clinical studies are carried out in accordance with uniform standards provided by regulatory requirements and internal operating procedures which determines a high quality of obtained data.
The clinic reviews agreements in short terms: within 1-2 weeks
The clinic personnel makes expertise of a Protocol and prepares a commercial proposal of a clinical part of a study
Completion of a questionnaire about possibilities of the clinical center and potential enrollment to a clinical study and assessment of project performance