Scientific & DSMB Statistical Support

Our statistical team collaborates partners with study teams to develop, monitor, and analyze study data using an extensive range of statistical methods.

Overview

Statistical Support

Our biostatisticians have extensive experience in monitoring a broad variety of clinical trials encompassing different disease areas and disease characteristics, and a variety of trial designs and product categories.

Independent Data and Safety Monitoring

Our broad experience with clinical trials and Independent Data Monitoring Committees (IDMCs) allows us to understand and anticipate the unique needs of your study.

We tailor analyses and reports to properly address the key scientific questions of each study, and convey its findings in a meaningful manner.

Planning

Execution

Validation

Our monitoring reports provide succinct risk-benefit information for periodic safety monitoring.

Expert Study Design

Our experienced and proficient team of statisticians aid in study design and protocol development, provide statistical input into study parameters and randomization guidelines, and monitor studies for treatment toxicities.

Independent Data Monitoring Committees (IDMC) Support

A member of the statistical team is designated to attend all IDMC meetings in order to discuss the pending data findings and explain the intricacies of the reports. The biostatistician performs interim analyses as needed and any follow-up analyses if so, requested by the IDMC.

Our Statistical Team

Our statistical team provides guidance on the optimal statistical and study design needed to address the scientific hypothesis, and works closely with the data management team to assist in case report form development, randomization guidelines, and monitoring plans.

The Frontier Science statistical team has nearly 20 years of experience serving as an Independent Statistical Center (ISC) to Independent Data Monitoring Committees (IDMC) for randomized industry trials, developing and validating confidential study monitoring reports that evaluate drugs, biologics, and devices in a broad spectrum of disease areas.

  • We collaborate on protocol design and provide input on the appropriate statistical methods to best address study goals

  • We provide high quality and responsive statistical support

  • Biostatisticians produce tables, figures, and listings of all specified analyses, both in the interim and after study conclusion

  • Biostatisticians produce tables, figures, and listings of all specified analyses, both in the interim and after study conclusion