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Dear Friends,
2015 was a year of major progress for TransCelerate BioPharma. We've made great strides in focusing on areas of inefficiency in clinical trials, and created tangible solutions that drive efficient, effective and high-quality delivery of new medicines. Serving as a platform for cross-industry collaboration, we continue to bring together some of the best minds in biopharmaceutical research and development to uncover more opportunities to transform the drug development process.
What are some of our recent accomplishments?
We released a Common Protocol Template, which provides a model clinical trial protocol template containing simplified, common structure and language to streamline protocol development and approvals across stakeholder groups such as investigative sites, regulators, sponsors and patients
Our Quality Management System initiative has developed a Concept Paper Vision & Outline describing a proactive approach and flexible framework for holistically managing quality across the spectrum of clinical activities
With the release of a new Risk Indicator Library, additional updates on technology considerations, central monitoring capabilities and detecting data quality issues in clinical trials, our Risk-Based Monitoring (RBM) Initiative continued to uncover new dimensions of interest in RBM and ways to share real-world adoption learnings with the broader industry
We launched our Placebo and Standard of Care (PSoC) Data Sharing Initiative and have begun pooling and converting PSoC data from Member Companies into a single consolidated database. Our team also released a white paper detailing guidance on the applications of a large historical PSoC database
We’ve released components of an Informational Program, part of our Site Qualification and Training Initiative, to guide site staff that are less experienced in or new to conducting clinical research, generating overall simplification and enhancement to the clinical trial site qualification and training process
We launched four new game-changing initiatives: eLabels and eConsent, which aim to create electronic information channels to help industry better understand elements of patient participation in clinical trials, Patient Awareness and Access, which seeks to improve patients’ experience in a trial and make trial information more transparent and patient-friendly, and eSource, which will assist trial sponsors in achieving more efficient data gathering processes.
As we continue to fulfill our mission and vision in 2016, we pledge to continue examining the process of clinical trials through an innovative lens, to help deliver new medicines to patients faster and improve the health of people around the world.
Stay tuned for more updates on what we're working on this year, and reach out to us at any time!
