ICSRs Management
Do you need to perform a timely collection and processing of safety case reports?.
Do you need to have a complete, hotline and comprehensive service ONE VIGILANCE 24 hours 7 days a week for 365 days a year? Are you looking for a team that will provide you with an outlet for all SAE/SUSARs during clinical trials, ICSRs on marketed products?. ·Â
We take care of it through our global and validated reporting platform ONE VIGILANCE.
Don’t hesitate to contact us for more information.
Why is it important?​
FOR PHARMA
Vigilance is a mandatory responsibility of the companies investigating the therapy assets at key entities
Established laboratories or manufacturers
Biotech startups
Research Cooperatives
Vigilance is a key responsibility of the MAH and therefore our dedication is addressed to ensure the safety and efficacy of human health products, especially pharmaceuticals, throughout the product life cycle, from development to post-marketing”.
When do clients need it?
FOR PHARMA
(pre)Clinical Research indicated in the Risk Management ProtocolÂ
Submission as Marketing Authorization Holder (MAH) before the Drug Agency (Medicine, Medical Device), e.g. AEMPS
Post-Authorization mandatory protocol · Inspections and audits
Why QbD Group?
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Tailored solutions
The actual approach of this service is up to you. It is fully tailored to your needs.
Contact us
Don’t hesitate to contact us so we can listen to your needs and provide you with the right service.
