Project Description

vigilance services including AE/SAE management and safety and SUSAR reporting services for clinical studies and non-interventional studies with medicinal products or medical devices

GKM delivers an extensive portfolio of vigilance services to support you. We offer AE/SAE management and reporting services for clinical and non-interventional studies with medicinal products or medical devices. We also assist you with tailored vigilance follow-up activities, case narrative writing, generating safety reports and thorough reconciliation – helping to ensure you receive consistent and accurate vigilance information on time, every time.

We understand that your company is unique – and so are your vigilance standards, processes and requirements. That’s why we adapt our vigilance service to fit your unique needs – from complete end-to-end solutions to selected services. We continuously train our staff on novel regulations and in line with your vigilance SOPs, so they know exactly what you need – and how to deliver it.

Vigilance services at GKM are provided by a team of experienced Clinical Safety staff members, most of whom are medical doctors. This allows us to communicate as peers with the study doctors – thus increasing their understanding for your vigilance needs – an essential motivation for rapid and correct reporting and responding to queries.

In this line of thought, we also train our in-house staff and CRAs to understand the unique vigilance requirements of your project, and we offer them continuous support throughout. We closely interact with you and the entire project team to keep everyone on the same page.

Further services

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