Eco-Security R&D Center LLC ensures the highest quality level of all services delivered
The activity of R&D Center divisions is fully regulated by Standard Operating Procedure (SOP)
This applies both to the clinics and laboratory
List of SOP of Eco-Security R&D Center LLC
NIC-ORG-001/02 – List of SOPs of Eco-Security R&D Center LLC
NIC-ORG-002/02 – Creation and handling of Standardized Operating Procedures of Eco-Security R&D Center LLC
NIC-ORG-004/02 – Records process at the Eco-Security R&D Center LLC
NIC-ORG-005/02 – Establishment procedure and job descriptions of research group members
NIC-ORG-007/02 – Regulation on Confidentiality
NIC-ORG-008/02 - Fire Safety
NIC-ORG-009/03 – Trainings for the Eco-Security R&D Center LLC personnel
NIC-ORG-010/01 - Regulations on the UNIT for Medicinal Drug Clinical Trial, Phase I and Bioequivalence of Eco-Security R&D Center LLC
NIC-ORG-011/01 - Regulations on the UNIT for Medicinal Drug Clinical Trial, Phase II-IV of Eco-Security R&D Center LLC
NIC-ORG-012/01 - Archive management for medicinal drug clinical trials at the Eco-Security R&D Center LLC
NIC-ORG-013/01 - Job descriptions of the research team members.
NIC-ORG-014/01 - Job descriptions of the research team members.
NIC-ORG-015/02 - Job descriptions of the research team members. Co-Investigating Physician
NIC-ORG-016/03 - Job descriptions of the research team members. Coordinator
NIC-ORG-017/01 - Regulation on Quality Control Department for medicinal drug clinical trials at the Eco-Security R&D Center LLC
NIC-ORG-018/01 – Use of information system, data storage and transfer, backup, data confidentiality at the Eco-Security R&D Center LLC
NIC-ORG-019/01 - Vendor Assessment Procedure for clinical study management
NIC-CR-002/03 – Procedure to sign the Informed Consent by clinical study subjects in the course of medicinal drug clinical trials
NIC-CR-003/03 – Receiving, storage, utilization of the test drug and research materials
NIC-CR-004/03 – Emergency Action Procedure
NIC-CR-005/03 – Medical Manipulation Procedure
NIC-CR-006/02 – Procedures to evaluate the test drug safety and tolerance
NIC-CR-007/03 – Maintenance of adverse events, result interpretation of lab tests and instrumental methods of diagnosis
NIC-CR-008/03 – Screening procedure for medicinal drug clinical trials, Phase I and Bioequivalence
NIC-CR-009/02 - Hospitalization procedure for healthy volunteers for medicinal drug clinical trials, Phase I and Bioequivalence
NIC-CR-010/02 - Bio-sample handling and storage procedure as part of medicinal drug clinical trials, Phase I and Bioequivalence at the Eco-Security R&D Center LLC
NIC-CR-011/01 - Volunteer dosing procedure as part of medicinal drug clinical trials, Phase I and Bioequivalence
NIC-CR-012/01 - Primary documentation use and maintenance for clinical studies at the Eco-Security R&D Center LLC
NIC-CR-013/02 - Volunteer randomization for clinical trials, Phase I and Bioequivalence
NIC-CR-014/01 – Registration of serious adverse events
NIC-CR-015/01 - Managment of visits by representatives of sponsor, contracting research organizations
NIC-CR-016/01 - Arrangement of meal for subjects of medicinal drug clinical trials, Phase I and Bioequivalence
NIC-CR-017/01- Access procedure to the drug storage by the personnel
NIC-CR-018/01 – Procedure for medical manipulations – measurement of vital parameters
NIC-CR-019/02 – Out-patient volunteer card filing and management as part of medicinal drug clinical trials, Phase I and Bioequivalence
NIC-CR-020/03 – Out-patient subject card filing and management as part of medicinal drug clinical trials, Phase I and Bioequivalence
NIC-CR-021/01 – Use of signatures and initials in primary documentation
NIC-CR-022/01 - Personal data handling policy for clinical study subjects at the Eco-Security R&D Center LLC
NIC-CR-023/01 - Audit arrangement and support
NIC-CR-024/01 - Monitoring visit arrangement and support
NIC-CR-025/01 - Procedure to approve and sign the contract for clinical trial, researches
NIC-CR-026/01 – Procedure and order for volunteer database management, contract with volunteer
NIC-CR-027/01 - Procedure for payment/reimbursement for volunteers/subjects
NIC-CR-028/01 - Bio-sample handling and storage procedure as part of medicinal drug clinical trials, Phase II-IV at the Eco-Security R&D Center LLC
NIC-CR-029/01 - Screening procedure for studies of Phase II-IV
NIC-EC-001/02 – Creation of the Ethics Commission at the Eco-Security R&D Center LLC
NIC-EC-002/02 – Agenda and meetings by the Ethics Commission at the Eco-Security R&D Center LLC
NIC-EC-003/01 - Expertise of reports on adverse events, clinical trial subject safety
