Gamze Alci

COMPANY Monitor CRO was founded in İstanbul (1999), as a pioneering Contract Research Organization in Turkey. We are currently the leading, most experienced and dedicated CRO with a 100+ full-time personnel with on-going monitoring activities for various international and national studies. CLINICAL TRIALS & CONSULTANCY SERVICES MEDICAL CONSULTANCY • Clinical trial planning and design • Recommendations for future studies/development • Regulatory strategy identification TRAINING • Basic medical training • Clinical trials trainings • Good Clinical Practice (GCP) training for study monitors, investigators, research staff and site coordinators MEDICAL WRITING AND SUBMISSION • Protocols • Case Report Forms • Abstracts • Trial documentation and archiving • CRF, eCRF and ICF translations into local language and adaptation to local requirements • Study reporting in line with ICH-GCP requirements • Study Design and creation of Study Synopsis • Manuscript writing DATABASE MANAGEMENT • Database Design • Data Collection and Entry • Drafting and Finalization of Data Management Plans • Data Validation Cleaning and Query Writing and Handling • Electronic Data Handling • Medical Dictionary Management and Medical Coding • SAE Reconciliation • Quality Controls • Statistical Analysis PROJECT MANAGEMENT • Observation • Bioequivalence • Phase I, Phase II, Phase III REGULATORY AUTHORITY APPLICATIONS AND APPROVALS • Initial Application, preparation for Ethics Committee • Initial application file preparation for Regulatory approval • Follow-up of applications • Preparation of files for regulatory and administrative changes during study • Pharmacovigilance reporting to EC’s and Regulatory Authority • Applications to RA for site coordinators • Institutional review board SITE OPERATIONS • Site selection and feasibility • Site contracts and agreements • Site monitoring • Site coordinator outsourcing PHARMACOVIGILANCE SERVICES