Clinical Research Consultants, Inc. (CRC) is a Cincinnati ophthalmic regulatory and clinical consulting firm established in 1992 by Barbara S. Fant, Pharm.D. Public materials describe FDA IDE, 510(k), and PMA work for corneal, refractive, IOL, glaucoma, LASIK, CXL, and artificial iris programs, and CRC publishes that it has successfully filed over a hundred IDEs, pre-IDEs, 510(k)s, and PMAs. That is a solid fit if you only need FDA ophthalmic RA. bioaccess® is the LATAM first-in-human execution partner those same sponsors still need — Mexico (COFEPRIS), Panama (MINSA/CNBI), and the rest of a 19-country Latin American footprint — with U.S. FDA anchoring designed into the protocol. This page does not claim bioaccess® operated the public Ocumetics Mexico FIH or closed Adaptilens.
| Metric | bioaccess® | Clinical Research Consultants |
|---|---|---|
| What they are | FIH-only CRO for MedTech, Biopharma & Radiopharma startups — LATAM execution partner, not a U.S. RA boutique | U.S. ophthalmic regulatory and clinical consultant (Clinical Research Consultants, Inc.) — not a Latin American CRO |
| Geography | U.S. + 19 Latin American countries, 50+ pre-qualified sites | Cincinnati, Ohio (3308 Jefferson Avenue, Upper Level, Cincinnati, Ohio 45220) — established 1992 |
| Public leadership (their site) | Founded 2010 by two interventional cardiologists (one Harvard-trained); ACRP-certified project managers and monitors | President and Principal Regulatory Consultant Barbara S. Fant, Pharm.D.; Clinical Operations Manager Jodi Pitcher (ACRP CRA) — titles as published on crc-regulatory.com |
| Public specialty (their site) | First-in-human and early-feasibility across MedTech, including ophthalmic devices, with LATAM site execution | FDA RA/clinical for corneal, refractive, intraocular, and other ophthalmic devices — LASIK, CXL, artificial iris; core areas also include orthopedic, surgical, and diagnostic devices |
| Typical job | Operate the LATAM FIH: country fit, ethics, import/export, monitoring, data, multi-country backstop | U.S. ophthalmic FDA pathway — IDE, pre-IDE, 510(k), PMA design, placement, conduct, and reporting as a consultant |
| LATAM first-in-human execution | CRO operator for Mexico (COFEPRIS), Panama (MINSA/CNBI), and 17 other Latin American markets | A Cincinnati RA/clinical consultant is not a LATAM FIH CRO; country execution is a separate sponsor or CRO job |
| U.S. regulatory role | In-house U.S. regulatory strategy: FDA Pre-Sub / Q-Sub, IDE, 510(k), De Novo, PMA, HDE, IND — designed as the anchor for LATAM execution | CRC is the US ophthalmic RA consultant sponsors already hire for IDE / 510(k) / PMA; that job and LATAM FIH execution are complementary, not substitutes |
| Timeline commitment | 12-month protocol-to-LPLV written guarantee — we work at our cost if we miss agreed milestones | Consulting / FDA-file timelines; a written multi-country CRO milestone guarantee is a different product |
| Typical per-patient cost (CRO vs US/EU) | $15K–$35K | $40K–$75K in US/EU benchmark ranges; a U.S. RA consultant's fee is a consulting line item, not a LATAM CRO package |
| Regulatory standard for devices | ISO 14155 + Declaration of Helsinki; data eligible for FDA submission/review under 21 CFR 812.28 | FDA and ISO standards for U.S. ophthalmic device filings, as published on crc-regulatory.com — category-level, not a CRC-specific timeline claim |
| Best-fit sponsor profile | Seed-to-Series-B ophthalmic (and other MedTech) startups that need a LATAM FIH operator alongside U.S. RA | Sponsors who only need FDA ophthalmic RA/clinical consulting and will run (or skip) LATAM FIH separately |
Comparison uses widely-known category facts about Clinical Research Consultants and published US/EU benchmark ranges — not Clinical Research Consultants-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
CRC is the U.S. ophthalmic regulatory and clinical consultant sponsors already hire. Public pages place Clinical Research Consultants, Inc. in Cincinnati since 1992, with Barbara S. Fant, Pharm.D. as President and Principal Regulatory Consultant and Jodi Pitcher as Clinical Operations Manager (ACRP CRA). CRC publishes expertise in corneal, refractive, IOL, glaucoma, LASIK, CXL, and artificial iris FDA work, and lists a 2019 Prix Galien nomination with HumanOptics AG for CUSTOMFLEX® ARTIFICIALIRIS. That is a real, useful FDA ophthalmic RA shop. If you only need that consulting job, CRC is a solid fit.
The search problem is different. Sponsors looking for CRC regulatory, Barbara Fant, or Clinical Research Consultants Cincinnati currently land on the consultant. bioaccess® still needs to own those searches because the CRO job is the one that chooses Mexico versus Panama versus another market, qualifies a site such as CODET Tijuana, designs the protocol against a target FDA submission, and operates ethics, import/export, monitoring, and data. A strong U.S. ophthalmic RA consultant can sit inside that plan; it does not replace LATAM first-in-human execution.
Two mailbox programs sit in this specialty and are named here so this page does not invent extra clients. Ocumetics (Dean Burns) has a public Mexico first-in-human; as of June 2026 an MSA/proposal was on file with bioaccess® — this page does not claim bioaccess® operated that FIH. Adaptilens ADP-FIH-002 (Liane Clamen) has been discussed with CODET Tijuana and a proposed Panama parallel — this page does not claim bioaccess® closed Adaptilens. There is no separate CODET compare page; CODET Tijuana is named only as that site. Do not mix Ocumetics with OcuMedex (Vizio™), which is a different glaucoma-microshunt program.
Data generated through bioaccess®-operated studies is produced under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 (for devices) or ICH E6 for drugs and biologics — a case-by-case regulatory determination, not a guarantee of clearance or approval. If you only need FDA ophthalmic RA, CRC is a natural fit. If you still need a LATAM FIH execution partner, bioaccess® is built for that job.
No. Clinical Research Consultants, Inc. (CRC) is a U.S. ophthalmic regulatory and clinical consulting firm in Cincinnati, established in 1992. It is not a Latin American CRO and not a hospital. bioaccess® is the LATAM first-in-human execution partner — Mexico, Panama, and 17 other Latin American markets — with U.S. FDA anchoring designed into the protocol.
Barbara S. Fant, Pharm.D. is President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (crc-regulatory.com). Public bio text describes 30+ years in pharmaceutical and medical-device R&D and FDA regulatory/clinical services for corneal, refractive, intraocular, and other ophthalmic devices, including LASIK, CXL, and artificial iris. CRC regulatory is the same Cincinnati firm. Jodi Pitcher is listed on CRC's site as Clinical Operations Manager and an ACRP-certified CRA — not as a bioaccess® employee.
Only in the narrow sense that both appear when a sponsor searches for ophthalmic FDA or first-in-human help. CRC is the U.S. ophthalmic RA/clinical consultant sponsors already hire. bioaccess® is the LATAM FIH execution partner those same sponsors still need. You can need both — CRC (or another U.S. RA firm) for the FDA file, and bioaccess® to operate Mexico or Panama. CRC is a solid fit if you only need FDA ophthalmic RA.
No. This page does not claim bioaccess® closed Adaptilens, and it does not claim bioaccess® operated the public Ocumetics Mexico FIH. Ocumetics (Dean Burns) has a public Mexico first-in-human; as of June 2026 an MSA/proposal was on file with bioaccess®. Adaptilens ADP-FIH-002 (Liane Clamen) has been discussed with CODET Tijuana and a proposed Panama parallel. Those two mailbox programs are named so we do not invent extra clients. OcuMedex / Vizio™ is a different glaucoma-microshunt program and is not Ocumetics.
There is no CODET intercept/compare page. CODET Tijuana is named here only as the mailbox site for Adaptilens ADP-FIH-002, with a proposed Panama parallel. bioaccess® is the CRO that can operate Mexico (COFEPRIS) and Panama (MINSA/CNBI) first-in-human studies — including ophthalmic device programs — when the sponsor still needs LATAM execution after (or alongside) U.S. ophthalmic RA consulting such as CRC.
You only need FDA ophthalmic regulatory and clinical consulting — IDE, 510(k), PMA, corneal / refractive / IOL / glaucoma / LASIK / CXL / artificial iris — and you will run or skip Latin American first-in-human execution separately. In that case CRC is a solid fit. bioaccess® is the better fit when the next milestone is a Mexico or Panama (or multi-country LATAM) first-in-human that still needs a CRO to operate ethics, import/export, monitoring, and FDA-bridgeable data.
Clinical data from studies conducted outside the U.S. under ISO 14155 and the Declaration of Helsinki is eligible for FDA submission and review under 21 CFR 812.28 (for devices) and comparable ICH E6 pathways for drugs and biologics. Acceptance is a case-by-case regulatory determination, not a guarantee of clearance or approval — our regulatory team designs the study with the target FDA submission (IDE, 510(k), De Novo, PMA, HDE, IND) as the anchor.
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