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 Awareness & Access
Clinical Research Awareness and Access seeks to increase awareness of and education about clinical research and its impact, improve potential participants’ access to clinical study opportunities and information on available studies, and enable more meaningful sharing of information with study participants.
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.
Patient Experience & Technology
The Patient Experience & Technology (PE&T) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce patient burden in clinical trials.
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.