TransCelerate Launches Two New Global Initiatives

The Placebo / Standard of Care Data Sharing Initiative is to create a framework for data sharing that allows for the leverage of data from previous studies respecting boundaries of informed consent. It offers the potential for more rapid understanding of safety signals to better manage patient safety during clinical trials, as well as identify statistical techniques that may deliver more accurate study design and statistical power calculations. The platform will be provided to Member Company biostatisticians to hopefully lead to improved protocol development, reduction in protocol amendments and a better understanding of disease models to identify the right targets. The goal is to maximize the value from the data generated from a patient participating in a clinical trial, as well as the R&D investment. 

The e-Labels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (e-Labels). This initiative will work to enhance label utility for patients, provide more consistent labeling approaches for sites and offers the potential to reduce clinical labeling timelines and provides cost efficiencies for sponsors. The Initiative, in collaboration with Regulatory Agencies, will develop guidance to facilitate implementation of e-Labeling.