Full-Spectrum Clinical Research Services

Our clinical trial management service covers the full lifecycle of your study, from site selection and activation to patient recruitment, monitoring, and final reporting. We act as a true extension of your team, coordinating every moving part so you can focus on your science.

We work across all phases and therapeutic areas, with a particular strength in the Mexican and Latin American market. Our team brings firsthand site experience, which means we anticipate problems before they arise and solve them faster when they do.

• → Protocol Development and Study Design
• → Investigator and Site Feasibility
• → Patient Recruitment and Retention Strategies
• → Site Monitoring

Navigating the regulatory landscape in Mexico and Latin America requires more than just knowledge. It requires relationships, experience, and the ability to anticipate how health authorities think. Althian has been working with COFEPRIS and other regional authorities for over 15 years.

We handle everything from initial regulatory strategy to submission, approval, and post-approval lifecycle management, so your study stays on track from day one.

• → Product Registration and Marketing Authorization
• → Import, Export and Customs Regulatory Support
• → Regulatory Training and Workshops

First-in-human and early-phase studies require an exceptional level of precision, safety oversight, and regulatory rigor. Our early-phase team has deep experience managing Phase I and Phase II studies, including bioavailability and bioequivalence trials, in compliance with ICH-GCP, FDA, and COFEPRIS standards.

Mexico offers competitive advantages for early-phase research, including a diverse patient population, experienced investigators, and access to underrepresented therapeutic areas. Althian helps you take full advantage of those opportunities.

Patient safety is at the center of everything we do. Our pharmacovigilance team provides continuous adverse event monitoring, safety reporting, and signal detection throughout the life of your study, and beyond, into post-approval surveillance.

We operate in full compliance with ICH E2A-E2F guidelines, COFEPRIS requirements, and international safety reporting standards, ensuring your study meets the highest global benchmarks.

Clean, reliable, submission-ready data doesn't happen by accident. Our data management team builds robust collection frameworks from the start, implements rigorous QA/QC processes throughout the study, and delivers analysis-ready datasets that meet regulatory expectations.

We work with industry-standard EDC platforms and can integrate seamlessly into your existing data infrastructure, whether you're running a single-site study or a multi-country program.

Post-marketing surveillance and real-world evidence studies are increasingly important for sponsors looking to demonstrate long-term value, support reimbursement decisions, and maintain regulatory compliance after approval.

Althian designs and executes observational studies, registries, and patient-reported outcome programs across Mexico and LATAM, generating the real-world insights that matter to payers, regulators, and patients alike.