Biometrics

Biotrial’s Biometrics Group provides support for the collection, management, analysis, and reporting of data from Preclinical to Phase I-IV clinical trials.

 

 

biotrial-biometrics

More about our Biometrics Services

Our Biometrics Unit has gathered a great deal of experience applicable on the following types of projects:

  • Preclinical Studies
  • Phase I / Clinical Pharmacology
  • Phase II / III / IIIb Trials
  • Phase IV Observational/NIS
  • Retrospective Trials
  • Early Access / Expanded Access
  • Meta-Analyses and Pooled Projects
Analyst Working With Business Analytics And Data Management System On Computer To Make Report With Kpi And Metrics Connected To Database. Corporate Strategy For Finance, Operations, Sales, Marketing
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Tools and Standards

Data standards

  • CDISC compliant (SDTM, ADaM, SEND)
  • Define.xml, ADRG, cSDRG, nSDRG
  • Deliverables for FDA and PMDA submissions
  • ICH
  • FDA 21 CFR Part 11

Biotrial Tools

  • SAS® for deliverables programming
  • EDC: Medidata Rave® and Clincase®
  • ePRO: Medidata® and Clincase®
  • Randomization (IRT, IWRS), Drug Supply, Coding, PV modules
  • Phoenix WinNonlin®

Added values

Iteration

Methodology and Solutions Consulting

Experts that help sponsors design successful trials

Information Service

Solutions tailored to project needs

Tools and project teams that bring value to a sponsor project

Experience (1)

CDISC Expertise

Providing CDISC deliverables to sponsors since 2009

Wide

Therapeutic Area expertise

Expertise in the collection and analysis of various specific endpoints

Our team

Our team includes experienced, dedicated and highly skilled Data Managers, Biostatisticians, Study Builders, Programmers, Medical Coders, CDISC Experts, Pharmacokineticists and Medical Writers.

Our Biometrics Team can help you at any stage of your project and provide a personalized service with an organization adapted to your needs.

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Brief Introduction to Services

Take a moment to watch this video for a quick introduction to Biotrial and learn more about what we do.

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