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

Monitor CRO

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