Phase I – IV Clinical Trial and Site Management
Phase I – IV Clinical Trial and Site Management
Phase I – IV Clinical Trial and Site Management
- Site and investigator selection
- 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 Design and Protocol Development
Phase I – IV Clinical Trial and Site Management
Phase I – IV Clinical Trial and Site Management
- 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
Medical Device Clinical Research Management
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
Medical Device Clinical Research Management
Medical Device Clinical Research Management
- Clinical Evaluation
- Support Services in PMS and PMCF Processes
- Summary of Safety and Clinical Performance (SSCP)
- Regulatory Consultancy
- Trainings
Observational Studies
Electronic Data Capture
Observational Studies
Project Management
Electronic Data Capture
Observational Studies
Electronic Data Capture
Electronic Data Capture
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 report
- Full article
- Poster
Medical Translation
Training
- Investigator Meeting
- Monitor and Investigator training
- Good Clinical Practices and current legislation training
- CRA school