UPDATE ON March 25th, 2020
Federal Agency for Medicine and Health Products (FAMHP) recommends some specific measures for the COVID-19 emergency.
Meditrial manages several studies in Belgium and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice and support.
The Agency continues to process applications. During this period, electronic submission via e-mail is recommended.
Please visit the website for the original communication on the electronic file submission.
March 25th, 2020: FAMHP publishes a guidance on clinical trial management during COVID-19 pandemic.
March 24th, 2020: FAMHP issues directive on IMP delivery to patient who cannot access hospitals. For more details, please see the original communication.
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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This article provides general information and does not constitute regulatory, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
