AtoZ-CRO offers the following services:
CLINICAL STUDIES PHASE I-V
- Planning of clinical studies
- Generating Study Protocol
- Design and implementation of Case Report Forms (CRFs)
- Processing of applications for Authorities and Ethical permissions
MONITORING
- Recruitment and assessment of Study centres
- Initiation of Study centres
- Training of Investigators and their staff
- Monitoring of Study centres
- Source Data Verification (SDV)
- Checking of CRFs for Completeness and Correctness
- Maintaining communication between Investigators and Sponsor
- Coordination of Investigational Product (IMP) Flow
- Status Reports
PHARMACOVIGILANCE SERVICES
- Collecting and analyzing of (Serious) Adverse Events
- SAE database with the possibility of E2B reporting to European and US Regulatory Authorities
- Reporting of SUSARs
- Training of Investigators concerning (S)AE documentation and reporting
- QPPV on a contract basis
BIOMETRY
- Generation of Data Management Plan (DMP)
- Data Processing
- Preparation of Biometrical Report (ICH 09)
COORDINATING of IITs
MEDICAL WRITING
- Preparation of Final Study Report (ICH E3)
MEDICAL TRANSLATIONS
EPIDEMIOLOGY STUDIES
PROFESSIONAL STAFFING
TRAININGS & SEMINARS
- ICH-GCP Basic & Refresher Training for Investigators, Study Nurses and CRAs
- Basic Monitoring Training
- Communication in Clinical Trials Seminar