Therapeutic Areas

Therapeutic Areas

Overview

To increase the awareness of Therapeutic Area specific knowledge relevant for Statistical Programmers, Statisticians and Data Managers.

Objectives 

To prepare a comprehensive indication specific information related to:-

  • Description of Disease

  • Agency guidelines applicable for the corresponding Disease or Indication

  • Clinical Trial Endpoints

  • Clinical Trial Designs

  • Data Collection

  • Data Challenges

  • SDTM Data

  • ADaM Data

  • Statistical Analysis

To review and maintain information on indication specifics