Jason Lang, MD, MPH, Duke pediatric pulmonologist and associate professor of pediatrics, was recently named Medical Director of DCRI Safety Surveillance. Lang completed medical school and his residency in pediatrics at the University of Vermont College of Medicine, followed by a pulmonary fellowship at Children's Hospital Boston and a research fellowship at Harvard School of Public Health. He received his MPH from the University of Florida. Lang’s research interests are focused on clinical trial design, epidemiology and biostatistics, asthma, childhood obesity, and exercise and nutrition. He sees patients at the Duke Asthma, Allergy and Airway Center.
About the Safety Surveillance Group
DCRI Safety Surveillance ensures on-time ascertainment and clinical evaluation of serious adverse events (SAEs) and other safety events through the development and skilled implementation of protocol-aligned safety management processes. The team has access to best-in-class medical, regulatory, and technologic support, to ensure reliable and accurate safety processes and systems, customized for every project.
Capabilities
- Specifications and user-testing for configuration of a trial-specific safety database.
- Pass-through service, so the sponsor retains ownership of the safety database while the DCRI prepares the safety management plan (SMP), triages safety events, queries sites, processes updates, and forwards SAE reports.
- Reconciliation of safety event critical fields between clinical and safety databases.
- Ability to leverage the infrastructure of device/disease registries and networks to manage safety events for registry-nested trials efficiently.
- Safety consulting and investigator training.