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.

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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

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
  • Meta-analyses for efficacy and safety evaluations
  • Go-no go decision-making and justification
  • Statistical support for in- and out-licensing due diligence
  • Advisory committee statistical representation

Contact us today to schedule a call to discuss how Facet can use statistics to help you with your R&D needs