At their core, clinical trials are designed to collect information and produce insights to aid regulatory and medical decision-making. Every step of the clinical trial process should be taken with this goal in sight: clear, effective communication to aid the medical community and result in improved patient care.
Statisticians are the catalyst to good science. We aid in design, analysis, and interpretation of clinical data. All of those steps are important, but without clear communication to all stakeholders, the trial will fail to meet its goals and its potential.
ConfluenceStat, LLC specializes in clear, insightful statistical communication with regulators in preparing for regulatory meetings or FDA advisory panels.
With 20 years’ experience in statistics and clinical trials and over a decade designing, analyzing, and presenting the most innovative Bayesian, adaptive, and platform trials, our founder, Jason Connor, is not only fluent in data collection/interpretation but is also adept at designing communication strategies. His strong narrative skills led him, at age 29, to be named Associate Editor of The American Journal of Gastroenterology for a six-year term. Over the course of his career, he has honed these “story-telling” abilities to assist in the approval of many drugs and medical devices. Whether designing a clinical trial, preparing a regulatory filing or preparing for advisory panel, we can assist you in developing the most effective strategy to communicate with the various stakeholders involved in your clinical trial.
We can assist with IDEs, INDs, NDAs, BLAs, 510ks, and PMAs. We also specialize in innovative designs and submissions for rare diseases.