Le Ly Thi Tran

Tran Thi Le Ly, Pharm, is a leading expert in the field of Clinical Trials, with nearly 20 years of experience conducting research both in Vietnam and internationally. She has successfully led numerous complex, multi-center clinical trials across domestic and international hospitals, strictly adhering to global standards. With in-depth knowledge of both Vietnamese regulations and international regulatory requirements, she efficiently manages the entire research lifecycle—including study initiation, regulatory submissions, site activation, monitoring, quality assurance, reporting, and preparation for audits and inspections.

Before joining VinUniversity as Director of Clinical Trials Unit, Ms. Ly held the position of Global Clinical Trial Manager at Sandoz Biopharmaceuticals (Germany), where she oversaw large-scale international clinical trials. Her contributions were instrumental in ensuring research quality and successfully passing inspections by stringent regulatory authorities such as the U.S. FDA, European Medicines Agency (EMA), UK MHRA, and other EU regulatory bodies. She previously held key roles at several multinational corporations, including Novartis, IQVIA, and Janssen Cilag.

One of her most notable achievements was serving as Clinical Trial Lead for the ARCT-154-01 COVID-19 vaccine trial conducted in Vietnam. Under her leadership, the study successfully recruited 19,500 participants in less than three months. Her team implemented rigorous oversight activities to meet demanding timelines during the pandemic while maintaining high standards of data quality. As a result, the study passed inspection by the PMDA (Japan) and subsequently received marketing authorization from both PMDA and EMA under the brand name Kostavia®, and is currently progressing toward submission to the U.S. FDA. (This was the first vaccine product approved based primarily on safety and efficacy data generated from a clinical trial conducted in Vietnam.)

At VinUniversity, Dr. Ly plays a pivotal role in advancing clinical research and scientific innovation, contributing to the development of a high-quality research ecosystem aligned with international standards