Alexandra Epple

About Alexandra Epple

Most clinical trials don\'t fail because of bad science. They fail because of execution gaps, and closing those gaps is what I\'ve spent 10+ years getting really good at. I\'ve led programs from both sides of the table - as a sponsor and as a CRO operator - and that experience shapes everything I bring to a program. I know how to design trials that are actually feasible to run, what separates high-performing sites from struggling ones, how to keep CROs accountable, and where the real risks tend to hide before they surface as problems. I\'m most valuable when I\'m brought in early, helping sponsors think through operational strategy before execution pressure sets in. What I do well: Building operational infrastructure from scratch; SOPs, governance, vendor frameworks and making it stick Managing CROs and external partners with real accountability, not just check-ins Turning feasibility and enrollment data into site and country decisions that hold up under scrutiny Walking into underperforming programs and quickly finding where the breakdown is Compressing timelines without cutting corners Leading cross-functional teams through complexity without losing momentum Getting up to speed in a new therapeutic area fast and becoming a credible operational voice in it Therapeutic Areas: CNS, rare disease, cardiology, women\'s health, oncology, and dermatology

Experience

1. Clinical Research Consultant

   Prism Health, Inc

   Jan 2023 — Present

   Part-time consulting role, concurrent with full-time positions at Sage Therapeutics (2023–2024) and PicnicHealth (2025–present). Prism Health is an AI-powered CRO providing end-to-end trial services for biotech and medical device startups. Led two First-in-Human Class cardiac device trials from site activation through milestone delivery, managing CRO performance and budget adherence. Authored 15+ SOPs and training templates aligned with global GCP and ISO 14155 requirements. Built AI-enabled dashboards providing real-time visibility into site performance, enrollment, and compliance risk.

Education

• Temple University

  Bachelors of Science

  2008 — 2012