First-in-Human FIH-12™ — Your Protocol-to-LPLV Timeline in Writing — bioaccess®

The first-in-human CRO for the Americas. FIH-12™ puts your protocol-to-LPLV timeline in writing, with fee credits if we miss it for reasons within our control. The program uses a 9-component clinical development methodology designed to deliver first-in-human data meaningfully faster and at lower cost than US/EU pathways.

Program Components

• Regulatory strategy and pre-submission
• Parallel ethics and regulatory filings
• Pre-qualified site activation
• Accelerated patient enrollment
• Real-time remote monitoring
• Streamlined data management
• FDA bridge data package preparation

Built for

• Seed-to-Series-B startups whose next milestone is first-in-human data
• A defined device, drug or radiopharmaceutical with core preclinical evidence in hand
• An intended FDA pathway (Pre-Sub, IDE, IND, 510(k), De Novo, PMA or HDE) or an investor milestone tied to human data
• Founders who need the timeline in writing for their board and investors

Timeline guarantee

If we miss the protocol-to-LPLV timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV. Full terms in your proposal.

Change control

Fixed scope. Fixed fee. Written timeline. Change orders are triggered only by the items listed in your proposal, such as sponsor protocol or design changes, delays in sponsor-supplied product, force majeure, or changes in law. Nothing else reopens the price.

What's in the FIH-12™ fee, and what isn't

One fixed fee covers the work below. Pass-through costs are agreed line by line in your budget before the study starts. Your exact scope and amounts are in your proposal.

In the FIH-12™ fee

• U.S. regulatory strategy: FDA Pre-Submission (Pre-Sub/Q-Sub) and IDE planning, captured in your U.S. Regulatory Anchor Plan
• First-in-human protocol and ISO 14155 compliance setup
• Ethics committee and national regulatory submissions
• Site selection, qualification, contracting and activation
• Investigational-device import logistics and customs paperwork
• Patient recruitment, enrollment and retention program
• Clinical monitoring by ACRP-certified monitors
• Electronic data capture (EDC) and data management
• Biostatistics and the clinical study report
• Weekly sponsor reporting
• At no extra cost: 48-hour Pre-Sub Gap Analysis, FIH Budget & Timeline Blueprint, Investor-Ready Clinical Data Room template and a monthly board-ready progress report

Outside the fee (pass-through costs, agreed in your budget up front)

• Site and hospital fees
• Clinical-trial insurance premium
• Ethics committee (IRB) and Ministry of Health submission fees
• Translations
• Import duties and shipping
• Travel

Supplied by you

• A clinical-ready investigational product (and any comparators)
• Technical and quality documentation on the agreed schedule
• Timely answers on the protocol, consent forms and data queries
• A device or product design that stays frozen for the study

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