What Is RWE
Randomized controlled trials establish efficacy under controlled conditions — but the questions that matter after approval are different. How does this treatment perform in older patients, in patients with comorbidities, in patients who take other medications? How does it compare to existing options in everyday clinical practice? Real-world evidence is designed to answer exactly those questions.
For sponsors operating in Mexico and LATAM, real-world data from this population is increasingly valuable — to regulators, to payers, and to the healthcare systems making decisions about access and reimbursement.
What We Do
We design and execute both prospective and retrospective observational studies to assess the safety, effectiveness, and outcomes of healthcare interventions in real-world patient populations across Mexico and LATAM. Our studies are designed to meet the methodological standards expected by regulators, payers, and the scientific community.
Following product approval, we conduct post-marketing surveillance studies to monitor safety and effectiveness in real-world conditions — fulfilling regulatory obligations to COFEPRIS and generating ongoing evidence of product value in the Mexican and LATAM market.
We incorporate patient-reported outcome measures into our real-world studies to capture the patient experience — quality of life, treatment satisfaction, symptom burden — providing a dimension of evidence that clinical endpoints alone cannot deliver.
We generate real-world evidence to support market access and reimbursement decisions in Mexico and LATAM — helping sponsors demonstrate the value of their products to payers and healthcare systems in the region.
Why LATAM
At Althian, we turn real-world data into real-world impact — for sponsors, for regulators, and for patients across Mexico and Latin America.
Monterrey, México