Study Start-Up Group
Comprehensive support for all types of studies
The Study Start-Up (SSU) Group is involved in all clinical study applications submitted to Competent Authorities (CAs) and/or Ethics Committees (ECs) for our full-service studies and can also support clients that only need help with submissions and interactions with CAs or ECs.
The SSU group is managed by a Group Manager SSU and handles clinical study and clinical investigation/performance study submissions for Investigational Medicinal Products (IMPs) and Medical Devices (MDs) including in vitro diagnostic (IVD).
Our Geographical Area
Within our geographical area, encompassing the Nordic countries, the DACH region (Germany, Austria, and Switzerland), and the United Kingdom, we support all types of studies, including interventional, observational, and other non-interventional studies such as retrospective data and sample collection projects.
By engaging experienced Local Regulatory Contacts and Regulatory Leads, we help ensure efficient study start-up, regulatory compliance, and smooth execution
Regulatory Considerations:
System preparation/Maintenance:
Document preparation:
