Tag: biometrics

Data Management & Biostatistics

Premier Research Names Jennifer Nezzer Vice President of Biometrics

Morrisville, N.C., September 2, 2021 — Premier Research has appointed Jennifer Nezzer, M.S., as Vice President of Biometrics. Nezzer, an industry-recognized expert in biostatistics with more than 25 years of global clinical research experience, will head Premier’s integrated Biostatistics and Medical Writing operational departments. Premier Research is a leading provider of clinical research, product development,...

Data Management & Biostatistics

Premier Insight 238: Back On Track: Data Rescue On Pediatric Rare Disease Trial

  Imagine rebuilding the engine in an ambulance carrying a critically ill patient to the hospital. Got it? Then you have a pretty good idea what it took to put this pediatric rare disease trial back on track. A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was...

Consulting

Premier Insight 243: The Question Was a Real Puzzle – and the Answer Changed Everything

Things were complicated enough to start. The customer, conducting a Phase 2/3 dose-finding/pivotal study for an adult growth hormone drug, changed its protocol midstream in response to regulatory feedback and was rethinking other aspects of the trial, adding to its complexity. For weeks, the sponsor’s requirements changed almost daily, severely testing an incumbent lab vendor...