Support
- CTIS Authorisation
- Protocol Review (Security)
- Bibliographic Searches in global databases
- Scientific-medical writing support
- VF training
- Support during audits
Clinical Trials
Vigilance is an integral part of clinical trials, providing ongoing
monitoring and assessment of the safety of investigational products.
- Our Clinical Trial Services -
Eudravigilance
- Support in the company’s Ata: SPOR
- Support in the Pharmacovigilance Responsible Person Register: QPPV/RP
- SUSARs reporting
- Product registration in the XEVMPD dictionary: EU Substance number, EU MP Number
Case Management
- Pre-assessment of expectancy
- Medical evaluation
- SAE/SUSAR/Pregnancy Management: Data Entry, Quality Control
- Generation of CIOMS-I for all reported cases
- Maintenance of own validated database: VigilAzierta
Safety Reports
- Data Exchange Agreements: SDEA
- Safety Management Plan: SMP
- Development Safety Update Report: DSUR
- Annual Trial Monitoring Report
- Database reconciliations
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