ITALY activates safeguard procedures for clinical trials during pandemic
The Italian Medicines Agency provides indications regarding the management of clinical trials in Italy during the COVID-19 (coronavirus disease 19) emergency. The guidelines describe the measures to manage clinical trials during the emergency and the exemptions granted. Download in English.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
