FIH Budget & Timeline Planner — bioaccess®

Native six-question planner for first-in-human medical device studies in Latin America. Returns an indicative regulatory route, country sequence, timeline to first patient, evidence outcome, comparable case study, and an indicative site-cost range. Results appear immediately as inputs change — no email required.

What the Planner Returns

• Indicative regulatory route based on device class and prior FDA interaction
• Country sequence for execution across Latin America
• Timeline to first patient (weeks) tuned by preclinical status and patient count
• Target evidence outcome (FIH, EFS, IDE-supporting, or CE / registration)
• Comparable bioaccess® case study
• Site & per-patient cost range using the LATAM benchmark of $15,000–$35,000 per patient (CRO fees, regulatory/ethics, pass-through, and contingency are quoted in the reviewed roadmap)

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