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
Company Details
- Employees
- 120
- Founded
- -
- Address
- Cumhuriyet Mah. Yeni Yol 1 Sok., Now Bomonti Blok No:2 Kat:7 Ofis No:58,turkey
- Industry
- Research Services
- NAICS
-
Scientific Research and Development ServicesResearch and Development in the Physical, Engineering, and Life SciencesResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Website
- monitorcro.com
- Keywords
- Monitoring and Project Management Clinical Research, Medical Consultancy, Medical Writing and Submission, Regulatory Authority Applications and Approvals, Database Management, Site Operations, Training, Pharmacovigilance Services.
- HQ
- Istanbul, Şişli
Monitor Cro Questions
Monitor Cro's website is monitorcro.com
Monitor Cro's LinkedIn profile is https://tr.linkedin.com/company/monitor-cro
Monitor Cro has
120 employees.
View email and phone details for 120
employees at Monitor Cro.
Monitor Cro's industry is
Research Services
Monitor Cro's top competitors are
Medismart Contract Research Organization,
Quadro Cro,
Medex Smo,
Klinar Cro,
Vital Cro,
Crm Tıbbi İlaç Araştırma Ltd. Şti.,
Atlas Cro,
Omega Cro,
Mycro Klinik Araştırmalar Ve Sağlık Hizmetleri A.ş.,
Altis Cro.
Monitor Cro's categories are Research Services
Monitor Cro's founding year is 1999
