Cost of running clinical trials in Chile

Clinical trial cost in Chile depends on study scope, and the structure keeps it predictable without a quality trade: for medical device studies, a single ethics gate replaces multi-layer review, and experienced Chilean sites execute to ISO 14155 Good Clinical Practice.

Cost in Chile reflects three structural drivers. First, site and procedure costs in Chile run well below US and EU levels while the clinical standard stays international. Second, the authorization path for medical device studies has exactly one protocol gate — an accredited Ethical-Scientific Committee (Comité Ético Científico, CEC) — so sponsors are not funding months of stacked regulatory consulting across multiple review layers. Third, the 45-day CEC decision clock (extendable once by 20 days (Decreto 114/2010, art. 18, https://www.bcn.cl/leychile/navegar?idNorma=1032919), Decreto Supremo 114 of 2010) compresses the start-up burn: the most expensive phase of any trial is the phase where nothing is enrolling.

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