UNIT for Medicinal Drug Clinical Trial, Phase II-IV

The Unit for Medicinal Drug Clinical Trial, Phase II-IV is created to arrange and conduct clinical studies of medicinal drugs (CT), Phase II-IV and R&D activity in line with international and Russian norms and regulations for clinical studies at the R&D Center.

ACTIVITIES

• Managing and scheduling clinical trials, Phase II-IV and research works at the R&D Center premises
• 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.
• Elaboration of possibilities to carrying out a research at the R&D Center premises (research budget estimation, availability of R&D Center resources for specific study) execution of the contract between the sponsor/CRO and the 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, coordination of all research parameters between the Customer, Principal Investigator and the R&D Center Manager.
• Approval of the Agreement provisions with employees as follow: Principal Investigator, Chief Accountant, lawyer, R&D Center Manager. The original contract (additional agreements to the contract, annexes, etc.) is kept at the Unit for Medicinal Drug Clinical Trial, Phase II-IV.
• Participation in SOPs preparation/updating.
• Preparation for audits by sponsors and monitors of contractual research organizations and corrective actions taken.
• Clinical trials management, Phase II-IV and research works at the R&D Center premises
• Approval and filing of registration, reporting and primary documentation in the course of studies.
• Interaction with the Ethics Committee and supervisory bodies (Ministry of Health of the Russian Federation, etc.) at all stages of drug clinical trials, Phase II-IV.
• Provision of internal document management (orders, bylaws, etc.) for clinical trials of medicinal drugs, Phase II-IV in process and pending, including research activities.
• Development of primary documentation. Filling and checking the specific documentation protocol, investigator file management. 
• Actions to ensure subject recruitment for running clinical trials, Phase II-IV and research works. Preparation, maintenance and statistical processing of databases on current clinical trials of medicinal drugs, Phase II-IV and research works.
• 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 issues related to the Unit for Medicinal Drug Clinical Trial, Phase II-IV.
• Research and educational activities of the Unit for Medicinal Drug Clinical Trial, Phase II-IV.
• Continuous education of the R&D Center personnel involved in Clinical Trial, Phase II-IV.
• Development of instructions for the personnel to be engaged in clinical trials of medicinal drugs, Phase II-IV, conducting briefings and classes.
• Rendering assistance to the business unit personnel to prepare publication materials, including those to be published in peer-reviewed journals.
• Involvement of the R&D Center personnel in scientific meetings, congresses, workshops, conferences.