Strategic Statistical Services

At Facet, we use advanced statistical principles and methodologies to help guide and accelerate the development of drugs, biologics, medical devices, and combination products. From innovative study designs to cutting-edge analytic techniques, our strategic statistical consultants help small teams do more with less.

Statistical Simulations Improve Probability of Clinical Success

For example, Facet conducted several statistical simulations to help a small pharmaceutical company decide on the most efficient clinical trial design and best efficacy endpoints to use to maximize their probability of success in the clinic. The simulations showed a very low probability of success on several declared efficacy endpoints with the sample size that the company was planning based on their funding constraints. Using additional simulations, Facet helped the company re-design the trial and use efficacy endpoints that were clinically meaningful and would have a high probability of success with the planned sample size. This work allowed the company to confidently proceed into the clinic.

High-Impact Strategic Statistical Services

Using innovative and cutting-edge statistical approaches, Facet helps our clients strategically accomplish their corporate and development goals more quickly and efficiently. To help our clients leverage every advantage, we provide the following high-impact strategic statistical services:

Trial simulations and probability of success assessments – Enables Sponsors to make more confident decisions in the face of uncertainty and allows Sponsors to evaluate a range of possible outcomes and plan for success

Expert statistical representation at FDA meetings – Statisticians play an important role in FDA meetings and working directly with FDA statisticians to ensure the design and methodology of studies will fulfill regulatory and business requirements

Trial Design – Traditional and innovative trial (e.g., historical control, bucket, adaptive) support and recommendations

CRO guidance and support – Facet’s statisticians serve as a Sponsor’s statistical representative to guide and oversee third-party statistical activities

Third-party validation of CRO results – Independent validation of nonclinical and clinical trial results

Begin your Facet success story today!

We also provide strategic guidance and support on the following:

Data mining for hypothesis generation
Trial design, protocol development, and review
Endpoint selection
Sample size estimation

Power calculation
Statistical Analysis Plan (SAP) development and review
Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC) membership and representation
Complex data interpretation and report writing