Centralized Biometrics

Effective Vendor Oversight Strategy

Increase quality, improve efficiency and cost savings thanks to an outsourcing model that highlights data as an asset and keeps all data related activities with one specialized vendor. This model creates considerable costs savings through standardization and improved efficiency. This yields a streamlined approach to oversight as required by ICH E6 (R2), consistent data strategy and handling and faster integration to support regulatory filings.

Key Elements of Centralized Biometrics

Improved Efficiency

  • Re-use of existing CRF pages to save on database build and statistical programming costs
  • Creation of global libraries of CRF pages and programs/macros
  • Utilization of one set of technologies so CRAs and Investigational Site staff benefit from familiarity
  • Better integration of studies across all phases with common assessment methods and increased efficiciency at time of reporting or regulatory filing
  • Centralized portal for viewing study data that facilitates data exploration, deployment of data visualization, and reporting across studies
  • Central warehouse for all clinical trial data and biometrics documents

Considerable Cost Savings

  • Volume discounts for EDC licensing fees and centralized hosting
  • Potential for FSP approach to all studies, creating additional cost savings

Maximized Partnerships

  • Enhanced understanding of your organization, needs and structure
  • Stable teams built on mutual understanding of working practices and shared vision
  • Development of tailored strategies and processes to meet your needs and expectations

Why choose Alira Health?

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:

  • Leadership with in-depth industry knowledge from our expert biostatistician with more than 20 years of experience
  • Dedicated, experienced in-house data specialists, with an average of over 10 years of industry experience
  • Tiered governance approach designed to mitigate risks, guarantee quality, and improve efficiency of project teams

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