Biostatistics

Biostatistics

Collaborative Analysis Planning

Our statisticians work very closely 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

“Clinical research is all about gathering data to draw conclusions about new treatments, confidently.  Without confidence, what have we really achieved?”
– Ron Marks – CSO, Clinipace Worldwide

Biostatistics Services

Our extensive Research Biostatistics Services (RBS) are tailored to meet your individual research needs, and can include:

  • Statistical support > study design, data safety monitoring boards (DSMBs), adaptive designs, manuscripts and abstracts
  • 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
  • Planned and exploratory analyses documentation
  • 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

Experience with Power

Led by a world-class statistician with more than 30 years of clinical experience, all of our 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 Services

Quality is the hallmark of any great team, and our biostatistical practice delivers GCP compliant analysis strategies, independent quality validation of formal deliverables to verify accuracy and audit readiness, as well as senior statistical review of all deliverables, from protocol writing through regulatory support.