Biostatistical Services

Count on us

Clinipace Worldwide’s extensive Research Biostatistics Services (RBS) are tailored to meet your individual research needs, and include:

  • Statistical support for study design
  • Detailed statistical analysis plans, according to sponsor’s protocol and developed in collaboration with sponsor scientists
  • Randomization that ensures integrity of treatment masking
  • Real-time reporting via the Clinipace Worldwide web-based reporting engine
  • Documentation that describes planned and exploratory analyses
  • Support for data safety monitoring boards (DSMBs)
  • Statistical support of adaptive designs
  • Analysis of epidemiological endpoints, patient reported outcomes and econometric measures
  • Production of tables, listings and figures, audit-ready at delivery
  • Continuing scientific collaboration on ad hoc analyses, regulatory feedback, and annual safety reports
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
  • Support for manuscripts and abstracts

Comprehensive Planning

Following a collaborative approach, Clinipace Worldwide statisticians work very closing with sponsor scientists and study managers to develop a comprehensive statistical analysis plan, including:

  • Overview of research objectives, sampling rationale and statistical power
  • Statistical methodology
  • Preparation of data dictionary for analysis of demographic, baseline, efficacy and safety data

Experience with Power

Led by a world-class statistician with more than 30 years of clinical trial experience, all Clinipace Worldwide statisticians have advanced degrees, and a deep understanding of:

  • Good Clinical Practices (GCP) as defined by the FDA and International Conference on Harmonisation (ICH)
  • Clinically-sound statistical methodologies
  • Clinical trial management and operations
  • Clinical Data Interchange Standard Consortium’s (CDISC) Study Data Tabulation Model (SDTM) and Operational Data Model (ODM)
  • SAS software
  • 21 CFR Part 11

Quality is the hallmark of any great team, and our practice delivers:

  • Analysis strategies that are GCP compliant
  • Independent quality validation of formal deliverables to verify accuracy and audit readiness
  • Senior statistical review of all statistical deliverables, from protocol writing through regulatory support