VAT number 04235771203
Audit
management
Clinical trials
monitoring
- Pre-audit activities
- TMF/eTMF completeness review
- Audit findings management (CAPA plan implementation)
- Conducting of all types of monitoring visits (remotely or on-site)
- Performing IMP accountability
- Reporting and managing quality concerns/issues, non-compliance and protocol deviations
- Monitoring report reviews
- Training of site staff
Training
Start-up activities
- Supporting with feasibilities and site selection activities
- Clinical Trial Agreement negotiations
- Clinical trial files preparation and maintenance
- Mentoring of Junior CRAs
- Conducting of Training visits in compliance with Italian CRO Decree DM 15Nov20211
- Supporting with ad-hoc training material preparation
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VAT number 04235771203