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.
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.