AtoZ-CRO offers the following services:

Clinical Studies Phases I – IV
        • Planning of clinical studies
        • Preparation of study protocols
        • Design and implementation of CRFs (case report forms) and eCRFs
        • Processing of applications for ethical votes and permissions (e.g. CTA, IND)
        • Regulatory affairs issues
        • Legal EU representative
Monitoring
        • Recruitment and assessment of study centres
        • Training of investigators and their staff
        • Monitoring of study centres including source data check
        • Maintaining communication between investigators and sponsor
        • Supplying the study centres with study supplies and documentation
        • Reporting
Pharmacovigilance
        • Collating, processing, analysing and notifying of ADRs occurring during clinical studies
        • SUSAR/ICSR submission to European Regulatory Authorities and CECs
        • EMA certified safety monitoring specialists for E2b submissions of SUSARs and ICSRs
        • Experience in medical, clinical and safety regulatory affairs in EU
        • Experienced in sponsor/pharmaceutical company registration with Eurdravigilance for clincial
           trials and marketed drugs
        • Offers QC for entered cases
        • 24-hour physician stand-by service in compliance with the obligation to notify of SADRs
        • Coordination of Data Safety Monitoring Boards (DSMB)
        • QPPV on a contract basis
Biometry
        • Data collation, validation, analysis and report, including sequential collation and analysis
Medical Translations
Medical Writing