Radiopharmaceutical Clinical Trials: AccelerateTheranostics Development in Latin America

Fast-track first-in-human studies and precision oncology trials with 40% faster approvalsand 50% lower costs versus US/EU pathways

Transform Cancer Care Through Targeted Radiopharmaceuticals

The global radiopharmaceutical market is projected to reach $26.5 billion by 2031, driven bybreakthroughs in theranostics and alpha-emitting isotopes like actinium-225.
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At bioaccess®, we specialize in accelerating radiopharmaceutical trials across Latin America,leveraging the region’s 650M+ population and streamlined regulatory frameworks to deliver results 40% faster than traditional pathways.

Why Partner with bioaccess®?

1. Unmatched Speed to Clinic

  • 4-6-week ethical approvals vs. 6-month delays in Europe.
  • 50% faster enrollement through our network of 30+ nuclear medicine centers.
  • 3-month INVIMA approvals in Colombia for PSMA/PRRT trials.

2.Cost-Efficiency

Cost Factor
Latin America
US/EU
Phase I Trial
$2.8M
$4.2M
Patient Recruitment
$8,000-$12,000
$25,000+
Site Activation
2-4 weeks
8-12 weeks

3. Theranostics Expertise

  • Dosimetry optimization for alpha/beta emitters (Ac-225, Lu-177).
  • Quantitative PET/CT protocols for PSMA/SSTR-targeted therapies.
  • Combination trials with checkpoint inhibitors and PARP inhibitors.

Latin America’s Strategic Advantages

Untapped Patient Populations

  • 80% treatment-naive candidates for FIH studies vs. 45% in Europe.
  • High prevalence of prostate cancer (74% higher mortality vs. North America).
  • Diverse genetic profiles validating therapies across ethnicities.

Regulatory Leadership

Colombia’s INVIMA offers 15% R&D tax credits and fast-track pathways for first-in-human radiopharmaceutical trials, with approvals 3x faster than ANVISA in Brazil. Our teamnavigates complex requirements, including:
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  • Radioactive waste management compliance.
  • GMP-certified radiopharmacy setups.
  • Multi-country ethics submissions

Advanced Infrastructure

  • 12 cyclotron facilities supporting N-13/F-18/Ga-68 production.
  • PET/MRI hybrid imaging at 8 partner sites.
  • Real-time dosimetry using OLINDA/IDAC 2.1 software.

End-to-End Radiopharmaceutical Services

Phase 0/I First-in-Human Trials

  • Radioactive waste management compliance.
  • GMP-certified radiopharmacy setups.
  • Multi-country ethics submissions

Theranostics Development

Latin America
US/EU
Phase I Trial
$2.8M
$4.2M
Patient Recruitment
$8,000-$12,000
$25,000+

Global Regulatory Strategy

  • IND/CTA Submissions for US/EU/LATAM markets
  • Orphan drug designation support
  • Post-trial access programs meeting WHO Essential Medicines List Criteria.

Why Competitors Lag

Traditional CROs lack our 15-year LATAM focus and nuclear medicine specialization:

  • Other International CROs: 68% higher costs for equivalent Phase I trials.
  • Local CROs: Limited radiopharma expertise and GCP compliance gaps.
  • Academic centers: Average 9-month delays initiating industry-sponsored trials.

Start Your Trial in 3 Steps

1

Strategic Consultation

  • Protocol optimization for Latin American populations.
  • Site feasibility analysis across 6 countries.

2

Regulatory Mobilization

  • Parallel ethics/INVIMA submissions.
  • Radiation safety compliance audits.

3

Execution & Monitoring

  • Real-time SAE reporting via Medidata Rave
  • Interim analyses at 25%/50%/75% enrollment

Contact Us to Accelerate Your Program

I look forward to connecting with you and exploring how we can bring your medical innovation to patients around the world more efficiently.

Request a Feasibility Assessment