OUTSOURCECRO SERVICES

• 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

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