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 illustrative sample budget 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
• Illustrative sample budget range from the bioaccess® rate card v2026.15 (the same model as the sample FIH budget): per-subject site payments, flat site-payment administration (not a percentage of grants), pass-throughs at cost, and 15% contingency on professional fees. Cash advances are not added on top. Not a quote or a fixed price.

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