How to Evaluate and Compare CRO Proposals for First-in-Human Trials in Latin America

· Julio G. Martinez-Clark, CEO, bioaccess®

A practical guide for medtech, biopharma, and radiopharma startups on how to evaluate, compare, and select CRO proposals for first-in-human clinical trials in Latin America.

How to Evaluate and Compare CRO Proposals for First-in-Human Trials in Latin America

A practical framework for medtech, biopharma, and radiopharma startups evaluating CRO partners for first-in-human trials in Latin America — what to look for, what to watch out for, and what questions to ask.

March 30, 2026

16

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

CRO

proposals

first-in-human

clinical trials

Latin America

budget

site selection

study synopsis

FDA

diversity plan

**Key Takeaways**

  • • Start with a 3-5 page study synopsis before requesting CRO proposals — without it, budgets will be imprecise and incomparable
  • • Total FIH costs in LATAM: $200K-$600K for 10-20 patients, 30-50% less than equivalent US studies
  • • Separate CRO fees from pass-through costs to enable true apples-to-apples comparison
  • • FDA diversity plans now impact LATAM site selection — plan proactively, not retroactively
  • • Red flags to watch for: lump-sum budgets without site-level detail, no regulatory timeline, unrealistic enrollment projections

**Who Is This For?**

This guide is for medical device CEOs, VP Clinical/Regulatory Affairs, and biopharma startup founders who are requesting, reviewing, or comparing CRO proposals for first-in-human trials — whether it's their first time selecting a CRO or they're re-evaluating their current CRO relationship.

The Most Consequential Decision Your Startup Will Make

Choosing a CRO for your first-in-human trial is one of the most consequential decisions a startup will make. Unlike Phase 2/3 trials where the study scope is well-defined, the regulatory pathway is established, and site networks are proven, FIH studies require a CRO that can navigate regulatory ambiguity, adapt to evolving protocols, and manage risk across unfamiliar jurisdictions.

The stakes are enormous: a misaligned CRO relationship can cost you 12-18 months of delay, hundreds of thousands of dollars in wasted spend, and — most critically — the confidence of your investors and board when milestones slip. Yet most device startups have never selected a CRO before and lack a framework for evaluating proposals.

This guide provides that framework — based on bioaccess®'s experience working with 50+ device and biopharma startups across Latin America.

Section 1: What Should a Complete FIH CRO Proposal Include?

A credible FIH CRO proposal should contain, at minimum, the following components:

  • Study synopsis or protocol reference: The proposal should be based on a specific study design, not generic assumptions
  • Site identification and qualification plan: Named sites, or at minimum, a described site search process with selection criteria
  • Regulatory and ethics committee submission plan: Country-specific pathway, expected timeline, and submission requirements
  • Detailed budget breakdown: CRO management fees, site costs, and third-party costs separated into line items
  • Timeline with milestones: Start-up, regulatory submission, ethics approval, first patient in, last patient out, database lock, final report
  • MSA/work order structure: Master service agreement framework, change order process, payment milestones
  • Team structure: Named project manager, medical monitor, regulatory lead, data manager — not TBD placeholders
  • Quality management: GCP compliance approach, monitoring plan, EDC specifications, audit readiness

**Missing Components = Red Flag**

If a CRO proposal is missing any of these components, it's either incomplete (ask for a revised proposal) or the CRO lacks the FIH-specific experience to provide them. Either way, proceed with caution.

Section 2: The Study Synopsis — Why It's the Starting Point

The single most common mistake startups make when requesting CRO proposals is doing so without a formal study synopsis. Without this document, CRO budgets will be imprecise — and incomparable — because undefined scope (number of sites, patients, endpoints, follow-up duration) dramatically changes cost.

A study synopsis is not a full protocol. It's a 3-5 page document that defines the essential parameters of your planned clinical study, providing enough specificity for a CRO to produce a meaningful budget estimate.

What the Synopsis Should Cover

  • Indication and device description: What is the device? What condition does it treat? What is the intended patient population?
  • Study objectives: Primary safety/feasibility endpoints, secondary endpoints if any
  • Patient population: Key inclusion/exclusion criteria, target age range, disease severity requirements
  • Number of patients: Proposed enrollment target (typically 5-20 for early feasibility, 10-30 for FIH)
  • Number of sites: Single-site vs. multi-site design
  • Follow-up period: Duration of post-procedure follow-up (30 days? 6 months? 12 months?)
  • Key procedures: Surgical implantation, imaging follow-up, laboratory tests, patient-reported outcomes
  • Regulatory strategy: Target country/countries, intended regulatory pathway, FDA submission goal

bioaccess® offers a complimentary FIH budget estimation tool that can help you develop initial scope parameters before formalizing a synopsis.

Section 3: Key Budget Components to Compare

When comparing CRO proposals, it's essential to separate budget components into three categories to enable true apples-to-apples comparison:

1. CRO Management Fees (30-40% of total budget):

  • Project management and coordination
  • Regulatory strategy and ethics committee submissions
  • Medical monitoring and safety oversight
  • Clinical monitoring (on-site and remote)
  • Data management and EDC setup
  • Statistical analysis and clinical study report

2. Site Costs (35-45% of total budget):

  • Hospital/facility fees (procedure room, recovery, imaging)
  • Principal investigator fees
  • Study coordinator compensation
  • Pharmacy services (if applicable)
  • Laboratory and pathology services

3. Third-Party/Pass-Through Costs (15-25% of total budget):

  • Ethics committee / IRB review fees
  • Clinical trial insurance premiums
  • Device importation and customs logistics
  • Central laboratory services (if applicable)
  • Translation services
  • Patient travel and accommodation (if applicable)

Typical FIH Budget Ranges in LATAM

Study TypePatientsLATAM Cost RangeUS EquivalentSavings
Simple EFS (single procedure)5-10$150K–$300K$300K–$600K~50%
Standard FIH (implant + follow-up)10-20$250K–$500K$500K–$1M~50%
Complex FIH (multi-visit, imaging)15-30$400K–$800K$800K–$1.5M~50%
Multi-country FIH20-30$500K–$1M$1M–$2M~50%

Section 4: FDA Diversity Plan Requirements

Starting in 2024, FDA requires sponsors of certain clinical trials to submit a Diversity Action Plan describing how enrollment will reflect the demographics of the disease population being studied. This has direct implications for LATAM FIH site selection.

For companies planning US submissions, a geographic split — typically 50% US / 50% outside the US — may be necessary to demonstrate diverse patient enrollment. Latin American clinical sites naturally provide diverse patient populations (ethnically, racially, and geographically), which can strengthen FDA submissions.

However, the diversity plan must be proactively designed into the study protocol, not added retroactively. Your CRO proposal should address:

  • How the proposed LATAM site(s) contribute to diversity enrollment goals
  • Whether the study design accommodates a US/OUS geographic split
  • How demographic data will be collected and reported
  • Whether the CRO has experience structuring studies for FDA diversity compliance

Section 5: Red Flags in CRO Proposals

Based on reviewing hundreds of CRO proposals over 15+ years, these are the most common red flags that should trigger further investigation:

  • Lump-sum budget without site-level detail: If the CRO can't break down costs by site, they haven't done the work to identify specific hospitals and investigators
  • No regulatory/EC timeline: A proposal that doesn't include a specific regulatory submission and approval timeline for the target country hasn't engaged with the local regulatory landscape
  • No clear escalation or change order process: FIH studies almost always require protocol amendments. If there's no defined process for handling changes, budget overruns are inevitable
  • No reference to GCP compliance: Any credible FIH CRO should explicitly describe their GCP (ISO 14155) compliance approach, monitoring plan, and audit readiness
  • Unrealistic patient enrollment timelines: If a CRO promises first patient enrollment within 60 days of contract signing, they're either cutting corners on regulatory/ethics submissions or being dishonest about timelines
  • TBD team members: If the project manager, medical monitor, and regulatory lead are all 'to be determined,' the CRO doesn't have a dedicated team ready for your project
  • No named sites or investigators: 'We have a network of sites' is not the same as 'We will conduct this study at Hospital X with Dr. Y as principal investigator'

Section 6: Questions to Ask Your CRO

During the proposal evaluation process, these questions will help differentiate between CROs with genuine FIH expertise and those applying Phase 2/3 playbooks to early-stage studies:

  • What is your experience in this specific country? How many FIH studies have you completed there?
  • Have you run a FIH study for this type of device/therapy? Can you share (anonymized) outcomes?
  • What is your relationship with the ethics committee at the proposed site? Have you submitted to them before?
  • How do you handle protocol amendments? What is the typical timeline and cost for a change order?
  • What happens if enrollment is slower than expected? What is your escalation plan?
  • Can you provide references from startup sponsors (not just large pharma) who have worked with you on FIH studies?
  • How do you structure your monitoring plan for a FIH study vs. a larger trial?
  • What EDC system do you use? Is it 21 CFR Part 11 compliant? Can the sponsor access data in real-time?
  • How do you handle device importation and customs clearance in the target country?
  • What is included in your price vs. what is pass-through? Are there any costs not reflected in this proposal?

Frequently Asked Questions

JM

Julio G. Martinez-Clark

CEO & Founder, bioaccess® · Has reviewed and authored 500+ CRO proposals for FIH and early feasibility studies across Latin America · 15+ years of direct operational experience helping 50+ startups navigate CRO selection and clinical trial execution.

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Ready to Request a Proposal?

If you're evaluating CRO options for a first-in-human or early feasibility study in Latin America, bioaccess® can provide a detailed, site-specific proposal within 2-3 weeks of receiving your study synopsis. Our proposals include named sites, named investigators, line-item budgets, and milestone-based timelines — not generic estimates.

Schedule a Strategy Call

Estimate Your FIH Budget

Related resources:

  • First-in-Human CRO Services — /first-in-human-cro
  • Early Feasibility Studies — /early-feasibility-studies
  • Case Studies — /case-studies
  • Clinical Trial Cost Calculator — /clinical-trial-calculator
  • Services Overview — /services

Frequently asked questions

How much does a first-in-human trial cost in Latin America?

Typical FIH trial costs in Latin America range from $200,000 to $600,000 for 10-20 patients, depending on the device complexity, country, number of follow-up visits, and monitoring requirements. This represents a 30-50% reduction compared to equivalent US studies. CRO management fees typically represent 30-40% of the total budget, with site costs, regulatory fees, insurance, and third-party services making up the remainder.

What is a study synopsis and why do I need one before requesting CRO proposals?

A study synopsis is a 3-5 page document that defines the essential parameters of your clinical study: indication, device description, patient population, inclusion/exclusion criteria, primary endpoints, number of patients, and follow-up period. Without this document, CRO budgets will be imprecise because undefined scope (number of sites, patients, endpoints, follow-up duration) dramatically changes costs. A well-defined synopsis enables apples-to-apples CRO comparison.

What is the difference between CRO fees and pass-through costs?

CRO fees cover the contract research organization's direct services: project management, regulatory submissions, medical monitoring, data management, statistical analysis, and report writing. Pass-through costs are third-party expenses the CRO manages on your behalf but does not directly perform: hospital/site fees, investigator payments, ethics committee fees, clinical trial insurance premiums, laboratory services, and device importation logistics.

Should I choose a global CRO or a regional specialist for my LATAM FIH study?

For first-in-human studies in Latin America, a regional specialist CRO with direct FIH experience typically outperforms global CROs. Global CROs are optimized for large Phase 2/3 multi-site trials and often lack dedicated FIH expertise, local regulatory relationships, and the operational flexibility required for early-stage device studies. A specialist like bioaccess®, purpose-built for FIH trials, offers deeper country-specific knowledge, established ethics committee relationships, and adaptive project management.

What does FDA require for clinical trial diversity plans?

As of 2024, FDA requires sponsors submitting certain applications to include a Diversity Action Plan describing enrollment goals that reflect the demographics of the disease population. For US submissions, a geographic split (e.g., 50% US / 50% OUS) may be necessary to demonstrate diversity. Latin American clinical sites naturally provide diverse patient populations, which can strengthen FDA submissions — but the diversity plan must be proactively designed into the study protocol, not added retroactively.

How do I know if a CRO has real experience in a specific LATAM country?

Ask for specific examples: Which hospitals have you worked with? Name the principal investigators you've collaborated with. How many studies have you completed in this country? What is your relationship with the local ethics committee? A CRO with genuine experience will have specific answers, named contacts, and documented case studies — not general claims about 'regional presence' or 'established networks.'

What happens if patient enrollment is slower than expected?

This is one of the most important questions to address in the CRO proposal. The proposal should include: realistic enrollment projections based on site-specific historical data, a clear escalation plan if enrollment falls behind (additional sites, expanded inclusion criteria), change order processes and associated costs, and milestone-based payment structures that align CRO incentives with enrollment performance.

Can I use clinical data from LATAM for FDA IDE submission?

Yes. Under 21 CFR 812.28, FDA accepts clinical data from foreign sites provided the study was conducted under GCP (ISO 14155), the data is valid, and subjects were protected. The CRO proposal should specifically address how the study will be structured to produce FDA-submissible data packages, including EDC setup, monitoring frequency, source data verification procedures, and regulatory-grade reporting formats.

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