Management Consulting - Izmir, İzmir, Turkey
Clinical Research Services1- Selection of site and investigators2- Initiation, monitorization and close out of study sites3- Progress reporting4- Safety reporting and monitoring5- Follow-up of EC and RA reporting6- Design and production of study newsletters7- CRA and Investigator training8- Investigators' meeting organization9- Financial agreement preparation for the investigators and institutionsMedical Services1- Case Report Form (CRF) design2- Informed Consent Form (ICF) writing3- Investigator's Brochure writing4- Medical translation and translation controlRegulatory Affairs Services1- EC and RA applications (index and timelines)2- IL application (index and timelines)3- Regulatory Body negotiations4- Preparation of revisions in collaboration with clientsRegulatory Affairs Regulations
Outlook
Apache
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