Our Approach
Pharmacovigilance is one of the most critical — and most continuous — obligations in clinical research. From the moment the first dose is administered to a patient, a system needs to be in place to detect, assess, report, and respond to any safety signals that emerge. That system needs to work in real time, and it needs to meet the expectations of COFEPRIS and international regulatory agencies simultaneously.
At Althian, our pharmacovigilance team provides end-to-end drug safety support — during clinical trials and beyond, into the post-approval lifecycle. We combine deep regulatory knowledge with a proactive, patient-centered approach to safety monitoring that sponsors can rely on throughout the life of their program.
What We Do
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We manage the collection, documentation, and processing of all adverse events and serious adverse events reported during your clinical trial. Our team ensures every report is captured accurately and completely, with the level of detail required for regulatory submissions.
Every SAE is reviewed medically, assessed for causality and expectedness, and processed within the timelines required by COFEPRIS and the study protocol.
Unexpected serious adverse reactions require expedited reporting to health authorities within defined timeframes — 7 days for fatal or life-threatening cases, 15 days for others. We manage this process end to end, ensuring no deadline is missed and every report meets regulatory requirements.
We also prepare and submit Individual Case Safety Reports (ICSRs) as required by the study protocol and applicable regulations.
We prepare annual Development Safety Update Reports summarizing the safety profile of investigational products, including a cumulative review of all safety data collected during the reporting period. DSURs are submitted to COFEPRIS and provided to sponsors in compliance with ICH E2F guidelines.
Beyond individual case management, our team continuously monitors the accumulating safety database for emerging signals — patterns or trends that may indicate a previously unrecognized risk associated with the investigational product.
When signals are identified, we conduct a thorough assessment and provide recommendations to the sponsor on appropriate actions, including protocol amendments, informed consent updates, or regulatory notifications.
Once a product is approved and on the market, pharmacovigilance obligations evolve but do not end. We provide post-approval safety monitoring to ensure your product remains in good standing with COFEPRIS — managing spontaneous adverse event reports, periodic safety reporting, and ongoing signal detection.
We also prepare Periodic Safety Update Reports (PSURs) and support risk management plan development and implementation as required by COFEPRIS post-approval conditions.
At Althian, we treat every adverse event report, every safety signal, and every regulatory deadline with the urgency and attention it deserves.
Our team combines deep knowledge of COFEPRIS safety reporting requirements with international pharmacovigilance standards — giving sponsors a single, reliable partner for drug safety across the full lifecycle of their program in Mexico and LATAM.
Monterrey, México