TransCelerate’s growing portfolio of initiatives focuses on the shared vision of accelerating and enhancing the research and development of innovative new therapies. These initiatives develop practical solutions to overcome inefficiencies in clinical trials and are drawn from the combined expertise of our members and industry collaborators.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Clinical Data Transparency
The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.
Clinical Research Access & Information Exchange
Clinical Research Access & Information Exchange seeks to provide a better window into information about clinical research and trial options and to contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.
Digital Data Flow
This initiative aims to move the drug development process from a current state of manual, study start-up asset creation (i.e. Case Report Forms, Procedure Manuals, Statistical Analysis Plans, and Schedule of Activities) to a future state of fully-automated, dynamic, study start-up readiness via an open-sourced, vendor-agnostic technical solution that will reduce cycle times and improve data quality for sponsors, third-party providers, sites and regulators.
The Investigator Registry initiative enhances TransCelerate’s Shared Investigator Platform, and 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.
Modernization of Data Analytics for Clinical Development
The Modernization of Data Analytics for Clinical Development Initiative aims to analyze methods for considering and validating novel statistical computing platforms to propose to Health Authorities and better enable them to support these platforms.
Pediatric Trial Efficiencies
The Pediatric Efficiencies Initiative thoroughly assessed potential solutions that would lead to faster access to new drugs for pediatric patients. Rather than continue as a standalone initiative, we will transition the focal points of pediatric populations across the broader TransCelerate portfolio, where appropriate.
Risk Based Monitoring
The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences.
Site Qualification and Training (SQT)
The Site Qualification and Training or ‘SQT’ Initiative collaborates with TransCelerate Member Companies, investigator sites, CROs and health authorities to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites.