Vital CRO

Vital CRO Clinical Research Organization Education and Consultancy Limited Company is a contract research organization. Vital CRO Klinik Araştırma Organizasyon Eğitim ve Danışmanlık Limited Şirketi bir sözleşmeli araştırma kuruluşudur. İlaç ve Tıbbi Cihaz Klinik Araştırmaları Organizasyonu Tel: 08503095743 Mobil: 05453963400 Drug and Medical Device Clinical Research Organization SERVICES *PHASE I – IV CLİNİCAL TRIAL AND SITE MANAGEMENT Ethics Committee and Ministry of Health applications Site Coordinator support Site initiation, monitorization and close-down visits CRF / e-CRF preparation Informed consent form design IVRS, IVRS preparation *TRIAL DESİGN AND PROTOCOL DEVELOPMENT Protocol preparation CRF design CRF/e-CRF Completion Guidelines ICF design and adaptation in compliance with local regulations and guidelines Statistical planning (Sample size estimation, randomization and power calculations) *MEDICAL DEVICE CLINICAL RESEARCH MANAGEMENT Development and Documentation of Clinical Research Strategy Preparation of files for application to Ethics Committee (EC) and Ministry of Health (MoH) Presentation of Ethics Committee applications and answering of related questions Presentation of Clinical Research to Ministry of Health and answering of questions regarding the study Project Management Statistical Evaluation Preparation of final Clinical Research Report *MEDICAL DEVICE REGULATION (MDR) CONSULTING Clinical Evaluation Support Services in PMS and PMCF Processes Summary of Safety and Clinical Performance (SSCP) Regulatory Consultancy Trainings *OBSERVATIONAL STUDIES *PROJECT MANAGEMENT *ELECTRONIC DATA CAPTURE *REGULATORY SUPPORT Ethics Committee and Ministry of Health applications *DATA MANAGEMENT AND STATISTICS Validation Database preparation Data entry Data management Sample size calculation Randomization Statistical analysis plan Statistical interim analysis Statistical final analysis *MEDICAL WRITING Protocol writing CRF / e-CRF design Clinical study repor

Web Sitesi

www.vital-cro.com

Vital CRO için harici link

Sektör

Araştırma Hizmetleri

Şirket büyüklüğü

11 - 50 çalışan

Genel Merkez

Sisli, Istanbul

Türü

Özel Şirket

Kuruluş

2022

Uzmanlık Alanları

research, clinical research, data management, Biostatistics, medical writing, site management organization, medical device regulation, pms, pmcf, medicine, Observational Studies, Project management, Research Protocol Design, Adverse Event / Serious Adverse Event Monitoring and Collection, Data Entry Support Service, Sample Size Calculation, Case Report Form Design, Electronic Data Entry, Preparing a Clinical Evaluation Report ve Center Feasibility and Selection