Sebnem Erfen's Contact Details

Sebnem Erfen's Company Details

Monitor CRO

İstanbul, İstanbul, Turkey • 92 Employees
Pharmaceuticals

COMPANYMonitor 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 SERVICESMEDICAL CONSULTANCY• Clinical trial planning and design• Recommendations for future studies/development• Regulatory strategy identificationTRAINING • Basic medical training• Clinical trials trainings • Good Clinical Practice (GCP) training for study monitors, investigators, research staff and site coordinatorsMEDICAL 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 writingDATABASE 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 IIIREGULATORY 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 boardSITE OPERATIONS• Site selection and feasibility• Site contracts and agreements• Site monitoring• Site coordinator outsourcing PHARMACOVIGILANCE SERVICES