Regulatory Biostatistics

Accomplishments

Our accomplishments include the following:

Approvals

  • We provided biostatistical support for the ColoGuard PMA approval involving sensitivity and specificity.
  • We provided biostatistical support for the Lokelma NDA approval involving serum potassium modeling over time
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Grants

  • We supported all aspects of biostatistics for program project grants to identify p27 and p53 biomarkers
  • We supported pre-clinical studies to evaluate microsphere implants to treat ischemia
  • We supported research in MRI imaging to diagnose heart disease
  • We supported interim analyses to evaluate new HIV therapies for SDAQ 
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Therapeutic Areas

  • Biomarkers (bladder, colorectal, lung, ovarian, prostate)
  • Cardiology (cardioplegia, ischemia, peripheral artery disease)
  • Diabetes (Type 1, Type 2)
  • Hepatology (NASH, acute, acute on chronic, chronic)
  • Imaging (MRI, opto-acoustics, ultrasound)
  • In vitro diagnostics (bladder, breast, colorectal, lung, ovarian, prostate)
  • Microbiomes
  • Nephrology
  • Neurology (Alzheimer’s disease, aneurysms, ASIB, bipolar depression, MS, stroke)
  • Nutrition (enteral, parenteral, obesity)
  • Oncology (breast, colorectal, gastrointestinal, melanoma, ovary)
  • Orthopedics (ankle, hip, knee, pelvis, shoulder, spine)
  • Pain (acute, chronic, local, metastatic, surgical)
  • Sports Injuries (concussion, surgery, trauma)
  • Transplantation