Clinical Biostatistics Services

GCR’s global clinical biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance that:

  • Accelerates decision making
  • Reduces risk of compromised timelines and errors
  • Ensures consistency and quality of global deliverables
  • Optimises efficiencies with robust processes and global infrastructure

Comprehensive Experience, Tailored Biostatistics Services

Our extensive clinical biostatistics services are comprehensive and can be tailored to meet the needs of your project:

  • Clinical development planning, study design, analysis and endpoint strategies, as well as supporting methodologies and statistical analysis plans
  • Randomisation schedule creation and integration with investigational product management, interactive voice response (IVR) and interactive Web response (IWR) systems, as well as other project planning needs
  • Scientifically sound interpretation and reporting of results with efficient, quality production of full-output deliverables
  • Real-time analysis presentations and frequent, automated and secure Web postings
  • Statistical consulting, design and operation of adaptive design studies for all phases of trials, from initial dose titration through post-approval services

Complete, Concise Biostatistics Reporting

Based on a well-developed plan, the statistical analysis implementation provides clients with timely, high-quality deliverables. We ensure complete, concise reporting through:

  • A centralised computing platform that unifies global biostatisticians and programmers, increasing productivity, saving time and enhancing data security
  • Analysis strategies that are International Conference on Harmonisation (ICH)-compliant
  • Production of audit-ready tables, listings and figures
  • New drug application (NDA) submission-ready data delivery in Clinical Data Interchange Standards Consortium (CDISC) format
  • Integrated submissions of statistical sections
  • Data and safety monitoring board (DSMB) output, interim analysis and investigational new drug (IND) safety updates
  • Development of comprehensive methods reports describing planned and exploratory analyses
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
  • Support for manuscripts and abstracts