How the FIH-12™ Works — Operating Model & Timeline

The FIH-12™ is the bioaccess® operating model for taking a first-in-human (FIH) or early feasibility study from a finalized protocol to last-patient-last-visit (LPLV). This page explains who it is for, what has to be true at the start, the milestones, who controls which risk, the exclusions and change-control rules, and the remedy if a covered delay occurs. Timeline figures are representative planning estimates based on programs bioaccess® has run since 2010.

Eligibility

• MedTech, Biopharma, or Radiopharma sponsors preparing an FIH or early feasibility study.
• A defined device, drug, or radiopharmaceutical with a stable design or formulation ready for clinical evaluation.
• Core preclinical evidence in hand (e.g. ISO 10993 biocompatibility, bench/functional testing, sterilization validation, ISO 14971 risk analysis, plus animal data where the risk profile calls for it).
• Intent to use the data to support an FDA pathway (Pre-Sub/Q-Sub, IDE, IND, 510(k), De Novo, PMA, or HDE) and/or an investor milestone.

Starting assumptions & sponsor dependencies

• The FIH-12™ clock starts once the protocol is finalized and the engagement is signed.
• The sponsor supplies clinical-ready investigational product and supporting documentation on the agreed schedule, and funds pass-through costs.
• Device/formulation design is frozen for the duration of the study; changes go through change-control.

Milestones: protocol to last-patient-last-visit

• Weeks 1–2 — Map the fastest path. FIH Roadmap: regulatory pathway, country/site recommendations, indicative timeline and budget.
• Weeks 2–8 — Regulatory & ethics submission. Dossier assembly, ethics committee (IRB/EC) and national regulator submission; representative approval windows run about 4–8 weeks.
• Months 2–3 — Site activation & first-patient-in. Contracting, activation, investigator training, investigational-product import, first-patient-in (FPI).
• Months 3–10 — Enrollment & monitoring. Enrollment, ACRP-certified monitoring, EDC data capture, safety reporting under ICH-GCP.
• ~Month 12 — Last-patient-last-visit (LPLV). Final protocol-specified visit and database lock.
• Month 12+ — Data package delivered. Biostatistics, clinical study report, and regulatory dossier structured for FDA acceptance.

Who controls what

bioaccess® controls: regulatory strategy and submissions, country/site selection and activation, investigational-product import logistics, ACRP-certified monitoring and data management, project management and reporting, biostatistics and the clinical study report.

The sponsor controls: investigational-product supply and timing, protocol decisions and design freeze, funding of pass-through costs, and turnaround on documents and queries.

The clinical site and investigators control: local enrollment pace, institutional contracting speed, and staff scheduling.

The regulator and ethics committee control: ethics (IRB/EC) review timing, national regulator review and authorization, and import permits.

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

Exclusions & change-control

• Sponsor-initiated protocol or endpoint changes after the design freeze.
• Changes to the device design or drug/radiopharmaceutical formulation.
• Delays in sponsor-supplied product, comparators, or documentation.
• Force majeure and changes in law or regulatory requirements outside our control.

When any of these occur, we document the impact, agree a change order, and re-baseline the affected milestones.

The remedy if a covered delay occurs

We agree on specific timeline milestones before the project starts. If we miss the written protocol-to-LPLV timeline for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV — no change orders, no additional fees. Full terms in your proposal. The guarantee covers milestones within our control; delays driven by the sponsor, site, regulator, or ethics committee, or by the exclusions above, are handled through change-control.

Regulatory note

Clinical data generated outside the U.S. is developed under ICH-GCP with U.S. regulatory anchoring. Under 21 CFR 812.28, the FDA may accept clinical data from studies conducted outside the United States to support a device submission when the applicable criteria are satisfied; acceptance is determined by the FDA on a submission-by-submission basis.

See the full FIH-12™ offer · First-in-Human CRO · FDA Acceptance of Foreign Clinical Data · Costs & Timelines · Book a free 30-min feasibility call