+90 212 257 03 21-26
Kultur Mahallesi, Kucuk Camlik Sitesi Esra Sokak No: 2A, A1 Blok, D:10 K:4, 34337 Etiler, Istanbul – TURKEY
• Outsourcing Clinical Study Coordinators for:
Phase I,II,III,IV, Observational Prospective and Retrospective studies
✓ Accompany CRA during Feasibility Studies
✓ Follow-up Ethics Committee and Regulatory Authority Submissions
✓ Accompany CRA during Site Visits:
Site Qualification Visits
Site Initiation Visits
Site Monitoring Visits
Site Closure Visits
✓ Ensure compliance with the protocol
✓ Participate actively in patient care
✓ Assist Principle Investigator forstudy related administrative works.
✓ Assist Principle Investigator for recording subject data into CRFs.
✓ Assist Principle Investigator for resolving CRF discrepancies and/or clarifications.
✓ Assist organizing lab. Samples collecting and ship ment to central laboratory.
✓ Assist Principle Investigator for prompt AE/SAE reporting
✓ Assist Principle Investigator for prompt CIOM/SUSAR reporting
✓ Participate in the informed consent process
✓ Participate actively in subject recruitment (source data recording)
• Outsourcing Clinical Research Associates for:
Phase I, II, III, IV, Observational Prospective and Retrospective studies
✓ Feasibility Studies
✓ Ethics Committee and Regulatory Authority Submissions
✓ Site Visits:
Site Qualification Visits
Site Initiation Visits
Site Monitoring Visits
Site Closure Visits
✓ Study Design
✓ Medical Writing
✓ Project Management
✓ Biostatistics, Interim and Final Study Reports
✓ Data Management
✓ Database and Software solutions
✓ Delivery of ICH-GCP and Clinical Research Trainings
• Outsourcing Clinical Trial Assistants for:
Phase I, II, III, IV, Observational Prospective and Retrospective studies
✓ Perform all duties and responsibilities in accordance with ICHGCP and other applicable guidelines.
✓ Perform feasibility studies in cooperation with a CRA.
✓ Perform clinical trial site co-monitoring responsibilities with a CRA.
✓ Assist in prompt AE/SAE reporting.
✓ Review Project related materials and critical documents for submission to regulatory departments in cooperation with a CRA.
✓ Participate in investigator/CRA meetings. Develop and maintain Study Master Files in cooperation with a CRA.
✓ Visitsites for co-monitoring(PSSV, MV) inaccordance to international and local regulations.
✓ Resolve CRF discrepancies and/or clarifications with a CRA.
✓ Review site regulatory file for completeness and accuracy on an on-goingbasis.
✓ Assist in tracking and reporting progress of study.
✓ May assist in the preparation and follow-up of in-house and onsite quality audits and regulatory authority inspections.
✓ Assist in maintenance of clinical trial timelines and trackers.
✓ Assist the development of clinical trial specific documents.
✓ Travel to differentsites for co-monitoring purposes.
✓ Participate in trainings.
✓ Maintain confidentiality regarding all the Projects involved.
• Archiving
• Local Depot Management Activities (Local depot contract and certification process..)
• Follow-up Clinical Trial Agreement Negotiation and Approval Process
• Site Management Organizations