Success Stories

LAT Research has a proven track record of delivering complex, high-impact clinical research and regulatory solutions across Latin America. Our operational excellence, regional insight, and scientific rigor are reflected in the following real-world examples:

Full-Service Phase III Trial for a Top 10 Pharma

  • Study Type: Full-service clinical trial (Phase III)
  • Therapeutic Area: Pediatric
  • Scope: Multinational trial management across LATAM
  • Enrollment: 330 pediatric patients enrolled in 14 months
  • Follow-Up: 4 years of patient monitoring
  • Performance: Dropout rate below 3%
  • Regulatory Outcome: Study accepted by the U.S. FDA, resulting in drug approval in 2020 under the Accelerated Approval Regulations

This trial showcases LAT Research’s capacity to manage long-duration, large-scale trials with strong patient engagement, operational efficiency, and regulatory success.

Real-World Evidence Study for a Top 10 Pharma

  • Study Type: Retrospective, real-world evidence (RWE) project
  • Scope: Full-service study management
  • Patient Population: 7,000 medical records reviewed
  • Focus: Patients with neglected conditions across Latin America
  • Timeline: Successfully completed within 18 months

This study highlights LAT Research’s ability to manage large-scale RWE initiatives, combining advanced data analytics with regional medical record expertise. It also reinforces our commitment to addressing unmet medical needs in underserved populations.

Regulatory Affairs Success in Rare Diseases

  • Scope: Proof-of-concept clinical trials submission for two rare diseases
  • Indications: Rett Syndrome (RTT) and Pitt Hopkins Syndrome (PTHS)
  • Country: Colombia
  • Regulatory Strategy: Applications submitted under INVIMA’s pilot program for orphan diseases and high unmet medical needs
  • Timeline: Submitted in early 2025
  • Outcome: Priority review and fast-track approval pathway activated

This case illustrates LAT Research’s deep regulatory expertise in Latin America and our ability to navigate innovative, accelerated pathways for sponsors targeting rare and complex conditions. Our regulatory team maintains strong relationships with authorities like INVIMA and proactively identifies mechanisms to reduce timelines and increase impact.

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