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.

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 an agreed milestone due to factors within our control, we continue working at our own cost until we deliver — no change orders, no additional fees. 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