Tuesday, January 9, 2024

Clinical Trial Lifecycle

Clinical Trial Lifecyle covers all below phases

  • Preparation of Study Protocol Document
  • Investigational New Drug Application submission to FDA
  • Study Startup process
  • Patient Recruitment
  • Data Management & Maintenance part of Studies
  • Study Closeout 
  • Publication of Clinical Study Report
  • Regulatory Approval


Clinical Trial Lifecycle can be pictorially represented as below:

The details of every phase in the lifecycle will be discussed in upcoming blogs.






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Pre and Post Award of a Clinical Trial