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TransCelerate BioPharma
United States
Приєднався 16 лип 2015
TransCelerate BioPharma Inc. is a non-profit organization that was created to improve the health of people around the world by accelerating and enhancing simplifying the research and development of innovative new therapies. Our mission is to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.
Our membership is made up of 20+ of the world’s most innovative and successful biopharmaceutical organizations who provide their best talent to collaborate and develop solutions to overcome industry inefficiencies. Our growing portfolio of Initiatives develops practical solutions to overcome inefficiencies in clinical trials and is drawn from the combined expertise of our members, and working collaboratively with health authorities, industry groups, research organizations and academia.
Our membership is made up of 20+ of the world’s most innovative and successful biopharmaceutical organizations who provide their best talent to collaborate and develop solutions to overcome industry inefficiencies. Our growing portfolio of Initiatives develops practical solutions to overcome inefficiencies in clinical trials and is drawn from the combined expertise of our members, and working collaboratively with health authorities, industry groups, research organizations and academia.
Vulcan UDP (Utilizing the Digital Protocol): Spotlight on Connectathon Results and Plans
This collaborative webinar recording is a presentation and panel Q&A for the latest news about Vulcan’s Utilizing the Digital Protocol (UDP), key insights from the recent Connectathon, and practical steps to prepare for implementation.
Panelists:
Hugh Glover,Technical Director, Vulcan
Vivian Combs, Executive Director of Clinical Trial Foundations, Eli Lilly
Chris Decker,President and CEO, CDISC
Dave Iberson-Hurst, USDM Product Owner, CDISC
Panelists:
Hugh Glover,Technical Director, Vulcan
Vivian Combs, Executive Director of Clinical Trial Foundations, Eli Lilly
Chris Decker,President and CEO, CDISC
Dave Iberson-Hurst, USDM Product Owner, CDISC
Переглядів: 218
Відео
Digital Data Flow (DDF) Solution Showcase: September 2024
Переглядів 303Місяць тому
This cohosted webinar recording is a presentation and panel Q&A highlighting the collaboration with CDISC that brings together sponsor companies, clinical solution providers, and key industry stakeholders.
Mastering Master Protocols and Advancing Platform Trial Research: a CC&R andEU-PEARL Collaboration
Переглядів 1522 місяці тому
This collaborative webinar recording is a presentation and panel Q&A that highlights the unique and impactful collaboration between TransCelerate’s Clinical Content & Reuse (CC&R) initiative and the Innovative Medicine Institute’s (IMI) EU-PEARL initiative.
In Comparable Terms: Driving Efficiencies to Simplify the Ability to Detect Class Effects in...
Переглядів 762 місяці тому
This webinar recording is a presentation and panel Q&A that provides an overview of BioCelerate’s SEND (Standard for Exchange of Nonclinical Data) Harmonization for Cross-Study Analysis initiative.
Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value
Переглядів 6524 місяці тому
This collaborative webinar recording is a presentation and panel Q&A to learn about Vulcan’s Utilizing the Digital Protocol (UDP), an umbrella project that brings together multiple initiatives to develop a digital representation of a study protocol. Panelists include: -Hugh Glover, Technical Director, Vulcan -Mary Lynn Mercado, Global Head Protocol Delivery & US Site Head, Regulatory Writing & ...
Is Your RWD Regulatory Ready Considerations When Preparing RWD for a Regulatory Submission
Переглядів 2165 місяців тому
This webinar recording is a presentation and panel Q&A to learn how the TransCelerate Audit Readiness Initiative has developed a set of considerations to support audit and inspection readiness for programs incorporating real-world evidence (RWE) and focusing on processes used to document data reliability. Panelists include: -Gracy Crane, International Regulatory Policy Lead (RWD & Data Policy),...
Pharmacovigilance Agreement Solutions You Didn’t Realize You Needed
Переглядів 3556 місяців тому
This webinar recording is a presentation and panel discussion about the overview of TransCelerate’s Pharmacovigilance Agreements Optimization (PVAO) Initiative, which includes a suite of solutions designed to help organizations enhance their PVA process. Panelists include: -Yvonne Gibble, Executive Director Pharmacovigilance Licensing & Business Development, Merck Sharpe & Dohme, LLC -Beth MacE...
Enabling iDPR: An Overview of TransCelerate’s Individual Participant Data Return Package
Переглядів 2108 місяців тому
This webinar recording is a presentation and panel discussion about the overview of TransCelerate’s Individual Participant Data Return (iPDR) Package, a comprehensive set of materials that provide general considerations to enable data return to clinical study participants. Panelists include: Paula Boyles, External Clinical Trial Data Sharing Program Lead, Pfizer Angela Bilkhu, Global Patient Pa...
What role can TransCelerate play to build a more inclusive approach to clinical research and care.
Переглядів 578 місяців тому
Find out how each panelist thinks that TransCelerate can play a role to build a more inclusive approach to clinical research and care.
How can we have clinical research out in the community and make it sustainable
Переглядів 438 місяців тому
Listen to our panelists talk about how our ecosystem can have clinical research out in the community and make it sustainable for the future.
How do you think about resiliency
Переглядів 488 місяців тому
In this clip, hear from the panelists as they discuss how each thinks about resiliency.
The journey of inclusion and backlash
Переглядів 288 місяців тому
Hear the panelists talk about the journey of inclusion and different backlash.
How do you think about inclusion on a personal level?
Переглядів 128 місяців тому
Learn about what inclusion means to each panelist on a personal level.
What does inspiring inclusion mean to you
Переглядів 278 місяців тому
Learn about how each panelist discusses what inspiring inclusion means to them.
TransCelerate BioPharma About Us
Переглядів 1,1 тис.8 місяців тому
TransCelerate BioPharma Inc. is a non-profit consortium of prominent R&D minds from some of the most esteemed biopharmaceutical organizations in the world to accelerate and simplify the discovery and delivery of new medicines that can change the world. As a united voice, their passion and expertise for innovation and discovery are wholly collaborative in this space, putting their collective ins...
Inspiring Inclusion: The Power of Pivotal Moments (International Women's Day 2024)
Переглядів 5108 місяців тому
Inspiring Inclusion: The Power of Pivotal Moments (International Women's Day 2024)
Rapid RWD Analyses to Support Safety Signal Assessments
Переглядів 4238 місяців тому
Rapid RWD Analyses to Support Safety Signal Assessments
Modernizing Clinical Trials Using Digitized Protocol Information
Переглядів 1,3 тис.11 місяців тому
Modernizing Clinical Trials Using Digitized Protocol Information
Diversity by Design Proactive Approaches to Facilitate Industry Wide Diversification of Clinical Tr
Переглядів 387Рік тому
Diversity by Design Proactive Approaches to Facilitate Industry Wide Diversification of Clinical Tr
Digital Data Flow Study Definition Repository Overview
Переглядів 263Рік тому
Digital Data Flow Study Definition Repository Overview
Offering Choice to Patients An Overview of the Personalized Clinical Trials Framework
Переглядів 336Рік тому
Offering Choice to Patients An Overview of the Personalized Clinical Trials Framework
Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication
Переглядів 503Рік тому
Understanding Case Reporting Transmission Networks in Drug Safety: The Impact of Replication
TransCelerate BioPharma-Privacy Methodology Solution Informational Resource
Переглядів 100Рік тому
TransCelerate BioPharma-Privacy Methodology Solution Informational Resource
Digital Data Flow: Time Points: Supporting Protocol Digitization with Complex Timing Components
Переглядів 251Рік тому
Digital Data Flow: Time Points: Supporting Protocol Digitization with Complex Timing Components
DDF: Integrating Clinical Content & Reuse (CC&R) and Digital Data Flow (DDF) Initiatives
Переглядів 254Рік тому
DDF: Integrating Clinical Content & Reuse (CC&R) and Digital Data Flow (DDF) Initiatives
Digital Data Flow: Supporting Automation of Case Report Forms Using Biomedical Concepts
Переглядів 391Рік тому
Digital Data Flow: Supporting Automation of Case Report Forms Using Biomedical Concepts
Solution Overview: Preparing to Engage with Health Authorities on Real World Evidence for Medicines
Переглядів 399Рік тому
Solution Overview: Preparing to Engage with Health Authorities on Real World Evidence for Medicines
Attitude of Gratitude for Patients & Care Partners Webinar
Переглядів 255Рік тому
Attitude of Gratitude for Patients & Care Partners Webinar
What You Need to Know about ICH E8 (R1): Using TransCelerate’s Tools to Help Interpret and Implement
Переглядів 1 тис.Рік тому
What You Need to Know about ICH E8 (R1): Using TransCelerate’s Tools to Help Interpret and Implement
Webinar: A Privacy Methodology to Improve Cross-Industry Data Sharing
Переглядів 376Рік тому
Webinar: A Privacy Methodology to Improve Cross-Industry Data Sharing
yes that is exactly what you need a music that puts you to sleep and low voices when you are learning something ... this a thumbs down video for sure
Interesting
💪 "promosm"
can a product made up of two 510k cleared medical devices and no biologics or drugs be classified as a combination device?
Is there a link to the spreadsheet? thanks
Great update! Thanks.
Any opportunities in clinical data management or clinical SAS from india people
Congratulations team TransCelerate on 10 years! Great effort. The need for this team to excel further is much more important then ever as we witness the pivotal change in how we conduct clinical trials and advances in medicine etc. Cheers!
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Excellent video! Can you provide a few insights on “How to evaluate whether RBM should be used in a particular observational study”?
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Character In the video It's great, I like it a lot $$
clinical template suite is open source ?
Congratulations to Michelle & the Risk project team. Great job on developing this video and associated content.
Outstanding! Thank you.
Great initiative for conducting Clinical trial. How to access this APP or form partnership with the company offering such great initiative design?
What creative agency did you use for your video?
What agency did you use for production?