Submission packages

Regulatory submissions

Regulatory submissions are critical milestones during study start-up and the outcome has a substantial impact on the timelines and conduct of the entire clinical study. Submission requirements vary between countries and the quality of submission packages can influence approval timelines. Changes are inevitable in clinical studies and these changes may require additional submissions (i.e., amendments) before implementation can take place.

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Clinical study start-up
Feasibility and site evaluation
Regulatory submissions
Site management
Clinical monitoring

CA and EC submissions

Streamline regulatory submissions

SCRO’s knowledge of local requirements for regulatory submissions and our focus on proactive planning and efficient communication are key to speeding up the submissions process and reducing timelines. Let us support you with your regulatory submissions during the entire clinical study period, from start-up to close-out.

  • Compiling submission packages
  • Ethics Committee (EC) submission
  • Competent Authority (CA) submission
  • Country-specific submissions (biobank, radiation committee, etc.)
  • Reporting in EudraCT
  • Interpretation of regulatory requirements
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