TransCelerate has published risk-based monitoring (RBM) recommendations for central monitoring and technology considerations. Two manuscripts published in the Drug Information Association’s Therapeutic Innovation & Regulatory Science journal, provide in-depth insights into these concepts pertinent to RBM methodology. Access to the two new manuscripts, the RBM methodology, subsequent updates and related materials can be viewed here.
Training Providers – To have your GCP training added to the list of those programs mutually recognized by TransCelerate Member Companies, please find information here.
Sites – To find common Sponsor forms mutually recognized by TransCelerate Member Companies and instructions for completion, please visit here.
TransCelerate BioPharma Inc. is proud to announce the appointment of Annalisa Jenkins, MBBS, MRCP, as Chair of its Board of Directors.
At launch, TransCelerate chose the following projects as initial areas of focus: development of risk-based site monitoring approach and standards, development of a shared user interface for investigator site portals, mutual recognition of study site qualification and training, development of clinical data standards, and establishment of a comparator drug supply model. In November 2013, TransCelerate announced expansion of the comparator network and site qualification & training project, as well as three new global initiatives.
Learn more about TransCelerate’s initiatives here.
Our ten visionary founding members launched TransCelerate to “increase quality in clinical studies and improve patient safety, enabled by broad participation and collaboration across the global research and development community.” They have since been joined by nine additional members, dedicated to accelerating the development of new medicines.
Learn more about our members here.
TransCelerate Celebrates First Anniversary
TransCelerate BioPharma launched in September 2012 to advance innovation in research and development (R&D), identify and solve common R&D challenges and further improve patient safety. The goal of our members, then and now, is to deliver more high quality medicines to patients.
Read more from TransCelerate’s CEO Dalvir Gill here.
Launched in September 2012, TransCelerate Biopharma Inc. aims to simplify and accelerating the delivery of innovative medicines to patients. With so much progress and so much future opportunity, we have continued to refine our focus. The new statements below reflect our organization’s continued commitment:
To improve the health of people around the world by accelerating and simplifying the research and development of innovative new therapies.
To collaborate across the global biopharmaceutical R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.
Our Core Values
Resources for Sites and Training Providers, including common Sponsor forms and criteria for GCP training that are mutually recognized by TransCelerate Member Companies, are available by clicking the button below.
TransCelerate executives and members present at many industry conferences and meetings all across the globe. Click on the button below to see a comprehensive list of these events.
TransCelerate has published risk-based monitoring (RBM) recommendations for central monitoring and technology considerations. Two manuscripts published in the Drug Information Association’s Therapeutic Innovation & Regulatory Science journal, provide in-depth insights into these concepts pertinent to RBM methodology. Access to the two new manuscripts is available here and here. Read more here.
CDISC and TransCelerate BioPharma Inc. announce launch of eSHARE. Read more here.
TransCelerate has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) that are shared with researchers, patients and others. The document describes an approach to apply when redacting or removing personal information from CSRs and other related clinical trial documents. Read more here.