Monitor CRO

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