Biometrics

ISS/ISE Reporting

Our Approach

Five steps to effective Integrated Summaries
  • Planning and Project Management: detailed project plan development, resource planning, risk management and project monitoring
  • Gap Analysis & Data Integration Plan: review of all available documentation and data for the studies to be integrated and creation of a Data Integration Plan
  • Statistical Analysis Plan: definition of the statistical methodology, algorithms and mock shells to be used for presenting the integrated data
  • Data Migration: after the migration of all datasets to the same consistent standard, data integration can begin according to the data integration plan
  • Analysis and Reporting: usage of the most up-to date templates and regulatory guidance to create the final integrated summary documents

 

Why choose Alira Health?

The CROS NT and Alira Health biometrics team has provided expert statistical guidance for over 500 projects, including regulatory communication and submissions, study-based data management, biostatistics, and statistical programming. You will benefit from our:

  • Exceptional customer service and site relations
  • In-depth expertise across the entire clinical trial process
  • Flexible and tailored service delivered by multidisciplinary and global teams
  • Frequent, transparent, and professional communication
  • Guarantee we will lead your study efficiently, safely, and successfully

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