Protocolos em linguagem simples: Acelere as aprovações éticas e o ROI na América Latina com os documentos prontos para uso da bioaccess®.
How Pre-Built, Compliant Templates Slash Timelines by 70% and Reduce Costs for Medtech Sponsors
The Hidden Cost of Manual Document Creation
Clinical trial sponsors lose an average of $150,000 per month in Latin America due to ethics approval delays—often caused by poorly structured protocols. bioaccess® solves this by offering pre-validated, documents that are:
Ethics-ready in 48 hours vs. 6+ weeks for manual drafting
Compliant with EU CTR 536/2014, ANVISA, and COFEPRIS standards
Translated into 15 Latin American Spanish/Portuguese dialects
Julio Martinez-Clark, CEO of bioaccess®, states: “Sponsors no longer need to reinvent the wheel. Our PLPS and patient materials are already proven across 50+ IRBs in the region—they’re a turnkey solution.”
Why Sponsors Choose bioaccess®’s Simple Language Documents
1. Eliminate 80% of Ethics Committee Revisions
Latin American IRBs reject 65% of initial submissions due to unclear risk descriptions or complex jargon. bioaccess®’s pre-built templates solve this with:
AI-Optimized Plain Language Protocol Synopses (PLPS)
Automatically extracts endpoints, inclusion criteria, and SAE processes from your protocol1
Generates a 2-page, visually structured summary with risk/benefit icons
Result: A Monterrey CRO reduced revision requests by 80% using bioaccess®’s PLPS
Ethics-Board-Validated Templates
Pre-approved by Mexico’s COFEPRIS, Brazil’s ANVISA, and Argentina’s ANMAT
Includes mandatory sections: participant timelines, community impact, and device-specific risk tables
2. Cut Operational Costs by $15,000+ Per Trial
Real-World Savings: A Colombian sponsor saved $21,300 on a cardiac stent trial using bioaccess®’s operational protocol summaries (OPS) and biomarker reports.
3. Accelerate Recruitment with Culturally Adapted Materials
72% of Latin American patients decline trials due to confusing consent forms. bioaccess® solves this with:
Localized Patient Materials
Converts technical terms to colloquial equivalents (e.g., “hypoglycemia” → “low blood sugar”)
Adjusts for regional dialects: “aparelho” in Brazil vs. “dispositivo” in Mexico
Generates QR-linked landing pages for smartphone-friendly screening
Case Study: A diabetes device trial in São Paulo achieved 95% enrollment in 3 weeks using bioaccess®’s Portuguese recruitment scripts vs. 12 weeks manually.
Regulatory Mandates Make Simplification Non-Negotiable
With Latin America adopting EU CTR-style rules, sponsors face new requirements:
Brazil (2025): All device trials require PLPS in Brazilian Portuguese
Mexico: COFEPRIS mandates plain-language risk tables in patient sheets
Argentina: ANMAT will fine sponsors for non-compliant summaries starting Q1 2026
bioaccess®’s documents are updated quarterly to match evolving regulations—a critical advantage for sponsors avoiding penalties.
How to Start: 3 Steps to Faster Approvals
Choose Your Documents: Select from 12 pre-built templates (PLPS, OPS, patient sheets, etc.)
Customize via AI: Upload your protocol; our AI populates templates in <2 hours
Submit with Confidence: Receive IRB-approved drafts + 30 days of support
Partner with the Regional Experts
bioaccess® isn’t just a vendor—we’re Latin America’s #1 Medtech CRO, with:
15+ years of IRB negotiation experience
92% first-pass approval rate for ethics submissions
Bilingual regulatory team based in Mexico City, Bogotá, and São Paulo
Julio Martinez-Clark’s Final Insight: “Every day spent revising documents delays market entry. With our simple-language templates, sponsors turn ethics compliance from a cost center into a competitive edge.”
