- Full participation across all stakeholders – clinical trial sponsors, sites, investigators, health authorities, patients, and their healthcare providers
- Information is fully used to improve the overall quality, design, and development process. We protect patients through shared, proactive safety science
- Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials
Newest Resources and Company Milestones
- TransCelerate announced that COO Janice Chang has been appointed as TransCelerate’s new Chief Executive Officer. Janice will assume the role on January 1, 2023. Janice, who joined TransCelerate in 2014, will succeed founding CEO Dalvir Gill, Ph.D., who announced his retirement after a long and successful career in drug development spanning over 30 years.
- In celebration of TransCelerate’s 10-Year Anniversary, our Board Members have been sharing their insights and thoughts about the successes and progress that TransCelerate has made over the last decade. You can watch these videos on our YouTube page to learn more about the overall impact TransCelerate has made within the R&D ecosystem. Q3’s experts include former Board of Directors contributor Peter Ronco, Head of Global Development, Janssen Research & Development.
Pulse On Progress Updates
Information Sharing & Harmonization
Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.
- In the Fall of 2020, the Clinical Content & Reuse Initiative released: “CSR Considerations for Studies Disrupted by the COVID-19 Pandemic.” Since that time, both ACRO and TransCelerate Member Companies have faced unprecedented interruptions to clinical trials caused by an increasingly diverse set of circumstances. ACRO and TransCelerate have taken the lessons learned from the past three years and published proposals to address these challenges in a new deliverable “Points to consider when developing a Clinical Study Report (CSR) for a clinical trial that has been disrupted due to unforeseen circumstances.”
- The Digital Data Flow Initiative concluded its “Connectathon: Organizing and Automating the Study Protocol” event in September. This virtual event focused on practical ways that companies have and can use the Standard Definition Repository Reference Information (SDRI) and the Unified Study Definition Model (USMD) created by CDISC. The study definitions repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards. The Minimum Viable Product (MVP) of the DDF initiative provides the foundation for the digital flow of study definitions data to enable interoperability between study builder, study definitions repository, and Electronic Data Capture (EDC) systems.
Improve the Patient & Site Experience
Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.
- The Diversity of Participants in Clinical Trials team launched a Sponsor Toolkit Program and Portfolio-Level Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT). The inclusion of diverse patient populations in clinical trials is of increasing importance to Health Authorities, including the U.S. Food and Drug Administration (FDA), and more inclusive trial practices are being strongly encouraged. This toolkit is designed to support sponsor efforts to leverage key portfolio and program/compound level diversity considerations to facilitate meaningful inclusion of diverse patient populations in the drug development lifecycle and includes guidance for sponsors across their portfolios and compound developments.
- The Patient Experience (PE) Initiative released a streamlined version of the Patient Protocol Engagement Toolkit (P-PET) Resource Guide. The P-PET Resource Guide provides sample questions for consideration during an engagement with patients and caregivers. Examples of visual aids are provided to facilitate clear communication of study design and protocol-related concepts to the patients. Additionally, the team released a P-PET Toolkit Quick Start Video to guide viewers through key considerations for utilizing the P-Pet throughout the patient engagement journey.
- TransCelerate published a new Patient Experience Solution Story, “Patient Input Leads to Study Design Change Reducing Patient Burden.” This Solution Story highlights how a TransCelerate Member Company implemented the Patient Protocol Engagement Toolkit (P-PET) to engage with patient advisory groups about a number of planned clinical trials designs.
- Members of TransCelerate’s Modernizing Clinical Trial Conduct Initiative were tasked with exploring what a more patient-centric clinical trial could look like in 2031 and identifying potential areas where TransCelerate could enable this vision. As a part of this effort, the team launched the Clinical Trials in 2031 and Beyond Report which aims to help the ecosystem understand some of the diverse drivers that influence the future of clinical trials. The report enables stakeholders in the ecosystem to prepare for potential scenarios to ensure patient-centric clinical trials in the future.
- The Modernizing Clinical Trial Conduct Initiative also launched its Participant Data Return Resource Pack which provides access to a consolidated set of resources from within the clinical research ecosystem that can assist with returning individual data globally. Sponsors can utilize these resources to rationalize and/or initiate efforts focused on enabling participant data return, as they provide foundational information to get started.
- The Patient Technology Initiative published the Solution Story “Patient Technology Toolkit Helps Advance a Sponsor Company’s Patient-Centric Objectives in Clinical Trials.” This case study demonstrates how a TransCelerate Member Company implemented the Patient Technology Implementation Framework to implement digital patient-facing technologies in clinical studies.
Enhance Drug Safety
Facilitate solutions that address a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts.
- The Pharmacovigilance Agreements Optimization Initiative (PVAO) hosted the “Let’s Make a PV Agreement: Three Solutions You Can Use to Enhance Your PVA Process.” Accompanied by a downloadable slide presentation, this video shows viewers how to implement TransCelerate’s Process Map, Table of Contents, and Glossary to their pharmacovigilance agreements processes, help support negotiations, and generate efficiencies across the PVA lifecycle.
Check Out Our Blog
- August 3, 2022: TransCelerate BioPharma in the News: Q2 2022
- September 29, 2022: SAS Blog: “New Clinical Trial Technologies for a New Era of Discovery”
- September 28, 2022: Outsourcing Pharma: “TransCelerate CEO: Speeding Drug Development a ‘Win-Win’ for All Concerned”
- September 21, 2022: Clinical Leader: “Apply Risk-Based Monitoring to Focus on the ‘Big 3’ – Timelines, Quality, and Budget”
- September 21, 2022: The Pink Sheet: “International Trial Organizations Address Reporting of Unforeseen Disruptions”
- August 9, 2022: UCB Patients Magazine: “Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation among the Clinical Research Workforces”
- July 26, 2022: Endpoints: “Q&A: CMO and Development Chief Dietmar Berger Says Sanofi is ‘Right There at the Table’ on Diversity Efforts”
- July 11, 2022: Clinical Leader/Life Science Leader: “The Case for Implementing TransCelerate’s Modernization of Statistical Analysis Framework”
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- BioCelerate Updates: http://transceleratebiopharmainc.com/biocelerate/
Mark Your Calendars
TransCelerate leaders and Member Companies are invited to participate and present at many biopharmaceutical research industry conferences and meetings across the globe to provide a perspective on industry challenges and clinical trial issues. Take a peek at a few places we will be presenting in the coming months. For detailed information on speaker presentations, visit the events page on the TransCelerate website.