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Start-Up Group

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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).

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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
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