Dostoevskaia, Zvenigorodskaia, Vladimirskaia, Dostoevskogo, h. 40-44
Ladozhskaia, Zanevskii av., 65, corp. 5
Zvezdnaia, Moskovskaia, av. Yuiri.Gagarina h.65,
pl. Muzhestva, av. Toreza h.8 (soon opening)
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Quality control

40 реферальных баз
40 реферальных баз
Проводим амбулаторный прием по всем клиническим направлениям
24 клинических направления
24 клинических направления
Центр полного цикла от составления документации до научной обработки данных и биостатистики
Центр полного цикла
Центр полного цикла
Лидирующие позиции по клиническим исследованиям в Северо-Западном регионе
56 постоянных <br>спонсоров
56 постоянных
спонсоров

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

 

Organizational SOPs

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.

 

Nurse

NIC-ORG-014/01 - Job descriptions of the research team members.

 

Nurse Research Pharmacologist/Pharmacist

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

 

Ethics Commission

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

 

 

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