A U.S.-based medical-robotics company (name withheld) — FIH Regulatory Pathway Built for a Venture-Backed Robotic Endoscopy System in Latin America

bioaccess® built the complete Latin America FIH pathway for a venture-backed robotic endoscopy system on behalf of a U.S.-based medical-robotics company (name withheld at the client's request). From site feasibility through regulatory submission architecture to professional regulatory closeout, bioaccess® delivered full-scope CRO services for this robotic endoscopy program.

Study facts

• Sponsor / company: A U.S.-based medical-robotics company (name withheld)
• Indication / area: Surgical Robotics
• Country: Latin America
• Study type: First-in-Human (FIH)

Key metrics

• FIH Pathway: Fully Built
• Region: Latin America
• Reg. Closeout: ~15 days

The challenge

The sponsor — a U.S.-based, venture-backed medical-robotics company — needed a CRO with deep robotic-procedure site relationships, experience submitting novel robotic investigational device applications to Latin American regulators, and the operational discipline to move at startup speed under investor pressure.

bioaccess® solution

The sponsor selected bioaccess® following a structured site feasibility process. bioaccess® presented comparative feasibility data from leading programs in Latin America and recommended a tertiary referral center with a robust procedural program. bioaccess® delivered comprehensive site feasibility, complete regulatory and Ethics Committee submission architecture for the novel robotic investigational device, regulatory checklists, budget negotiation support, Trial Master File infrastructure, investigator training coordination, and — when the sponsor pivoted the study to a different region — managed the full professional regulatory closeout in approximately 15 days.

Results

• Complete Latin America FIH regulatory pathway built for a novel robotic investigational device
• Tertiary referral site selected via structured multi-center feasibility comparison
• Full regulatory and Ethics Committee submission architecture delivered
• Investigator training coordination managed
• Professional regulatory closeout completed in ~15 days when the study pivoted to another region
• Trial Master File infrastructure, MSA legal review, and document translation workflows delivered

Frequently asked

What did bioaccess® do for A U.S.-based medical-robotics company (name withheld)?

The sponsor selected bioaccess® following a structured site feasibility process. bioaccess® presented comparative feasibility data from leading programs in Latin America and recommended a tertiary referral center with a robust procedural program.

Where was the A U.S.-based medical-robotics company (name withheld) First-in-Human (FIH) study run?

The A U.S.-based medical-robotics company (name withheld) First-in-Human (FIH) study was executed in Latin America by bioaccess® in the surgical robotics area.

What was the outcome of the A U.S.-based medical-robotics company (name withheld) study?

Reported outcomes for A U.S.-based medical-robotics company (name withheld)'s device: Complete Latin America FIH regulatory pathway built for a novel robotic investigational device; Tertiary referral site selected via structured multi-center feasibility comparison; Full regulatory and Ethics Committee submission architecture delivered.

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