Althian Clinical Research

Althian Clinical Research provides CRO and regulatory services across Mexico and Latin America, coordinating clinical studies from feasibility and start-up through reporting. Its portfolio also covers pharmacovigilance, clinical data and statistics, regulatory submissions, early-phase studies, and real-world evidence.

Clinical Trial Execution

• Manage multi-site studies from protocol through final report, covering site selection, recruitment, monitoring, regulatory coordination, and data management.
• Assess investigators, sites, and protocol-matched patient pools, then deliver feasibility reports, enrollment projections, and site activation.

Regulatory and Safety Operations

• Prepare COFEPRIS strategies, dossiers, submissions, authority responses, renewals, amendments, and lifecycle compliance for products and studies.
• Process adverse events and serious adverse events, including medical review, expedited reporting, ICSRs, DSURs, PSURs, and signal assessment.
• Train site staff and sponsor teams on GCP, COFEPRIS requirements and Mexican regulatory submissions through tailored workshops.

Clinical Data and Early Development

• Build and validate study databases on sponsor-preferred EDC platforms, resolve data queries, manage database lock, and produce statistical analyses and TLFs.
• Design and execute Phase I, first-in-human, dose-escalation, and BA/BE studies, using PK/PD data to guide dosing decisions.

Real-World and Access Evidence

• Design and execute prospective observational studies, registries, and patient-reported outcome programs across Mexico and LATAM.
• Generate real-world evidence on safety, effectiveness, quality of life, treatment satisfaction, and symptom burden for regulatory, payer, and reimbursement decisions.

Best Fit

• Sponsors seeking a Mexico or LATAM CRO for multi-site clinical execution, local regulatory coordination, and pharmacovigilance support.
• Teams needing regional feasibility, clinical data services, early-phase studies, or real-world evidence for regulatory and market-access decisions.