The European Medicines Agency (EMA) updated information on its dedicated task forces to deal
with the scientific, regulatory and operational challenges generated by the COVID-19 pandemic and initiated its business continuity plan.
The aim of these measures is to safeguard the Agency’s core activities related to the evaluation and supervision of medicines during the pandemic and to ring-fence resources dealing with COVID-19.
The task force involves four workstreams:
- Therapeutic response
- Supply Chain
- Business Continuity
- Impact and Human Resources.
For more details, please the original communication from the EMA.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- 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
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