Start-Up Group

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 we work with all types of studies (interventional, observational, and other studies e.g. retrospective data/sample collection) and engage staff from Clinical Operations and Regulatory departments as Local Regulatory contact Regulatory Lead.


Regulatory Considerations:

  • Legal Representation
  • Test Product and sample logistics (QP certification; import/export)
  • Submission requirements according to applicable legislation
  • Study type and test product classification

System preparation/Maintenance:

  • Prerequisites for submissions (e.g. appropriate user roles in submission systems such as EU Clinical Trials Information System ; CTIS; or local submission systems, medicinal product registration; organisation registration)
  • Maintenance of applications throughout the lifecycle of the study, including status tracking ; query response management and required notifications

Document preparation:

  • Compliance of published documents with applicable data protection legislation
  • Preparation of templates and forms required for submission

Don't miss out on the latest updates

Be the first to hear our breaking news at LINK Medical

Get in touch

How can we help you?

Contact us and we will tell you more