The Unit for Medicinal Drug Clinical Trial, Phase I and Bio-Equivalence is created to arrange and conduct clinical studies of medicinal drugs, Phase 1 and Bio-Equivalence, and research and development activity (hereafter "R&D") in line with international and Russian norms and regulations for clinical studies at the R&D Center.
24 CTs, Phase I and Bioequivalence done
1150 volunteers took part in the Clinical Trial Phase 1 and BE
As rated by the CRO Synergy Research Group "Clinical Trials in Russia Orange Paper":
ranked first by the BE studies for the Quarter III, 2016
Ranked first by the bioequivalence (BE) studies in 2016 in the Russian Federation
Management and scheduling of clinical trials of medicinal drugs, Phase I and BE, as well as R&D within the R&D Center facility
Data collection, establishment of business contacts with Russian and foreign enterprises and companies design of collaborated activity schedules.
Preparation of documents required to initiate interaction between the sponsor/contractual research organization and R&D Center.
Study of capacity to perform studies at the R&D Center
Assessment of potential capacities, benefits and risks posed to the Center providing that the scheduled study is held at the Eco-Security R&D Center.
Addressing the issue to open the Research Center (hereinafter referred to as the "RC") to the head of the R&D Center. Verification of relevant documentation.
Participation in SOPs preparation/updating.
Preparation for audits by sponsors and monitors of contractual research organizations and corrective actions taken.
Management of clinical trials of medicinal drugs, Phase I and Bioequivalence, as well as researches at the R&D Center
Approval and filing of registration, reporting and primary documentation for researches.
Interaction with the Ethics Committee and supervisory bodies (Ministry of Health of the Russian Federation, etc.) at all stages of drug clinical trials, Phase I and Bioequivalence.
Provision of internal document management (orders, bylaws, etc.) for clinical trials of medicinal drugs, Phase I and Bioequivalence in process and pending, including research activities.
Development of primary documentation. Filling and checking the specific documentation protocol, investigator file management.
Interaction with subject of the medicinal drug clinical trials, Phase I and Bioequivalence.
Preparation, maintenance and statistical processing of databases on current clinical trials of medicinal drugs, Phase I and Bioequivalence.
Submission of the trial conclusions to the R&D Center Manager upon the study completion and closure of the Center by the sponsor, ensuring of the research material archiving.
Coordination of activities held by the R&D Center clinical, diagnostic and scientific units on authorized issues.
Research and educational activities
Continuous education of R&D Center personnel involved in clinical trials of medicinal drugs, Phase I and Bioequivalence.
Development of instructions for the personnel to be engaged in clinical trials of medicinal drugs, Phase I and Bioequivalence, conducting briefings and classes.
Involvement of the R&D Center personnel in scientific meetings, congresses, workshops, conferences.
Notification of contract research organizations and pharmaceutical companies of the experience in management of biomedical researches and scientific capacities of the R&D Center.