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.
In 2016:
- 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
ACTIVITIES
- 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.
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