• Celerion Newsletter
Belfast - Center of Excellence for Respiratory

Celerion

committed to service excellence

Primary Navigation for Celerion

  • Home
  • About Celerion
    • Why Celerion?
    • Mission, Vision and Credo
    • Management Team
    • Who We Work With
    • Locations
    • Environmental Sustainability
  • Applied Translational Medicine
    • Key Elements of Success
  • Services
    • Global Clinical Research
      • AAHRPP Accreditation
      • Phase I and lla Studies
      • In-hospital Beds
      • Study Experience
      • Belfast – Center of Excellence for Respiratory
      • Early Cardiac Services
      • Hybrid Phase I/ECG Core Lab
      • ADME/Mass Balance
      • Microtracer Studies
      • USP <797> Clean Room
      • ClinQuick® Electronic Data Acquisition
      • Recruitment
    • Clinical Pharmacology Sciences
      • Modeling and Simulation
      • Study Design and Protocol Development
      • Data Programming
      • Biostatistics
      • Pharmacokinetics/Pharmacodynamics (PK/PD)
      • Medical Writing and Reporting
      • Streamlined Data Flow Process
    • Global Bioanalytical Services
      • Small Molecule
      • Large Molecule
      • Electronic Laboratory Notebook System
      • ADME/Mass Balance
    • Drug Development Services
      • Biopharmaceutical Development
      • Program and Project Management
      • Regulatory Affairs
  • Celerion Europe
    • Global Clinical Research
    • Clinical Pharmacology Sciences
    • Global Bioanalytical Services
    • Management Team
  • The Biosimilars Alliance
    • The Biosimilars Alliance – Overview
    • The Biosimilars Alliance – Benefits
  • Case Studies
    • Global Clinical Research
      • Responding to an Unexpectedly High Drop Rate
      • Mass Balance Study
      • Semen Clinical Trials
    • Clinical Pharmacology Sciences
      • Partnering with Biotechnology Companies
      • Partnering with Large Pharmaceutical Companies
      • Protocol Study Design and Development for Generic Studies
      • Difficult to Recruit Population
      • Consistent Database Structure for Programs of Studies
    • Global Bioanalytical Services
      • Improved Desmopressin Analysis of Clinical Samples
      • Optimized LC-MS/MS Method for New Observed Metabolite
      • Bioanalytical Support of Oncology Studies
      • High Throughput Bioanalytical Analysis
      • Partnering with Biotechnology Companies
      • Partnering with Pharmaceutical Companies
      • Development of an LC-MS/MS Peptide Method
    • Drug Development Services
      • Support of CMC to IND for Novel First-in-Class Small Molecule Drugs
      • Rapid Proof-of-Concept for Novel Drug Treatment for Rare Metabolic Disease
      • Proof-of-Concept Efficacy Clinical Study
      • European Biotechnology Company Seeking First-in-Human U.S. Clinical Study
      • Asian Biotechnology Company with CNS Compound
  • White Papers
  • Other Resources
  • News & Events
    • Press Room
    • Conferences
    • Symposia
    • Webinars
  • Participate in a Study
  • Careers
    • Message from the CEO
    • Culture
  • Spring 2013 Newsletter
  • Fall 2012 Newsletter
  • Spring 2012 Newsletter

Services > Clinical Pharmacology Sciences

Biostatistics

Celerion’s team of highly qualified statisticians routinely performs a large number of statistical analyses to deliver high-quality, submission-ready data for regulatory agencies.

Celerion’s statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often consulted to perform special calculations and summarizations of information for non-study-related issues for problem solving and process improvement.

SAS programmers perform statistical programming and data programming, as well as providing tables, figures and listings (TFLs) based on the analyses and format specified in the Statistical Analysis Plan, following either Celerion standards or client-specific requirements.

To ensure on-time delivery of quality data, Celerion has developed standard programs, analysis codes and output formats, in addition to a large number of macros to compile SAS output and streamline data delivery. In addition, data flow within Celerion systems (clinical, bioanalysis and PK/statistics) is automated and error proof.

Celerion is the first global CRO to utilize the fully integrated SAS® Drug Development platform to provide a centralized system for managing, analyzing, reporting and reviewing clinical research information.

Comprehensive biostatistics services:

  • Input on sample sizes and analysis of endpoints
  • Detailed statistical analysis plans
  • TFL generation including required statistical analysis
  • Consultation on statistical topics

See also...

Scientific Poster: Improve Efficiency and Productivity of Statistical Output

Case Study: Protocol Study Design and Development for Generic Studies

Scientific Poster: PK/PD Modeling of the Effect of IV Doses of Anzemet® and Its Metabolite on the QT Interval in Healthy Subjects

For more information contact us

Footer Naviation

  • About
  • Locations
  • Careers
  • Request a Proposal
  • Contact
  • Privacy Policy
© 2013 Celerion