Monitor CRO Company Profile, Contacts & Intelligence

Monitor CRO Overview

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

Headquarters

58, Tr

Website

monitorcro.com

Industry

Research Services

Founded

1999

NAICS

Scientific Research and Development Services, Research and Development in the Physical, Engineering, and Life Sciences

Company Email

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