Recent Milestones

Innovations Supporting Medical and Regulatory Needs


  • We provided biostatistical support for the first de novo approval involving Artificial Intelligence.
  • We provided biostatistical support for an approved device to resolve aneurysms using a Bayes design
  • We provided biostatistical support for two approved knee injection products using a Bayes design


  • We assisted in the award of a SPA for a suicidal ideation study
  • We devised a Bayes SAP for a cardiovascular device
  • We attended an FDA meeting to successfully negotiate performance goals for an aneurysm study
  • We defended the use of previous data towards regulatory clearance

Therapeutic Areas:

  • Alzheimer’s disease
  • Aneurysms
  • Breast cancer
  • Cardiology
  • Diabetic monitoring
  • Diabetic retinopathy
  • Gluten allergy
  • In vitro diagnostics (bladder, breast, colorectal, lung, prostate)
  • Knee injection therapy
  • Microbiomes
  • Obesity
  • Orthopedics
  • Renal injury
  • Suicidal ideation