Biostatistics

Our biostatisticians have an average of 10 years’ experience in the industry and bring expertise across multiple therapeutic areas including dermatology, ophthalmology, neurology, cardiology, and generics. We have the experience and technical expertise to analyze and communicate your trial data in meaningful ways and which make the greatest impact.

We work with Sponsors to form the best solutions for your program when it comes  to collecting, analyzing, and presenting your data–all while keeping in line with regulatory requirements. Our statisticians can work with you from the protocol design stage, to calculating the sample size and powering the study, to writing and reviewing the clinical study report. We integrate biostatistical activities with the full project plan to deliver your study results.

Our services include:

  • Clinical trial design
  • Sample size and statistical power determinations
  • Generation of randomization schemas
  • Development of Statistical Analysis Plans
  • Generation of tables, listings, and figures (TLFs)
  • PK and PK/PD analyses
  • DSMB participation
  • Statistical consulting

Statistical Programming

Our experienced team of Statistical Programmers have created custom macros and best practices that form our flexible, fast, and proven statistical programming framework — while our strict adherence to SOPs, extensive review process, and full-time QA team ensure the final data is of the highest quality. We provide the following statistical programming services:

  • Analysis datasets specifications development
  • Creation of derived datasets
  • Creation of tables, listings and figures (TFL)
  • QA/QC/validation of datasets and TFL
  • PK/PD parameter calculation
  • Creation of ISS(SCS)/ISE(SCE) analysis databases
  • Observational study analyses
  • Data mapping
  • CDISC services (SDTM, ADaM and Define.XML)
  • Post-marketing data analyses and reporting
  • eCTD submission support
  • Patient profile listings and figures
  • Patient summaries for narratives
  • Regulatory queries support