Clinical trial sponsors frequently invest significant time and resources in identifying qualified investigators and establishing study sites. The inability to obtain information around the site experiences and qualifications of an investigator often delays crucial trials. The Investigator Registry Initiative will create a shared repository of investigator contact details and some site-related data from consenting sites. This Initiative accelerates identification and recruitment of qualified investigators, which will avoid duplication of standard site qualification and the creation of investigator documentation, and thereby reducing cost and trial length.
The Investigator Registry Initiative will lessen the burden on clinical trial sites to constantly update multiple records. TransCelerate Member Companies will see reduced cost and improved time efficiency of the entire clinical trial process, and have an opportunity to store and view own-company site metrics through a comprehensive and global list of investigators.
TransCelerate, in collaboration with DrugDev, is working to streamline clinical trial processes by allowing TransCelerate Member Companies to pool investigator data together into a centralized, cloud-based resource. The resource will lead to faster identification and recruitment of qualified investigators based on proven past and will prevent duplication of site qualification activities or generation of investigator documents.
Shared Investigator Platform
The Shared Investigator Platform (SIP) will facilitate interaction between investigators and multiple clinical trial sponsors, enabling study planning, study start-up and study conduct activities while reducing the administrative burden on site staff.
Quality Management System
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.
Placebo and Standard of Care Data Sharing
The Placebo and Standard of Care (PSoC) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.