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Quarterly Updates from TransCelerate

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Summer 2024

 News At-a-Glance

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San Diego Success!

 

Another energizing gathering for TransCelerate at the 2024 DIA Global Meeting, thanks to great learning and sharing.

 

We were honored to present and participate in numerous conference sessions in San Diego and to record onsite interviews with Andy Studna from Applied Clinical Trials. TransCelerate COO Allison Cuff Shimooka talked with Andy about innovation in clinical research, and Vice President Rob DiCicco reflected on the state of AI in clinical research. Allison also put pen to paper to share her takeaways from the conference in this blog post.

 

Here’s to continuing these important conversations and seeing everyone at the 2025 DIA Global Meeting in Washington, DC!

Blankets and Bikes, for Good

 

Every year, TransCelerate dedicates time to community service. This year, our team partnered with WeHero to make a difference locally. 

 

We built 10 bikes for the Bicycle Coalition of Greater Philadelphia and crafted 14 cozy blankets for patients at the Children's Hospital of Philadelphia. 

 

It was a great day, and wonderful to see everyone’s dedication to positively impacting our community! 

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Member Leaders, Together

 

“There is something magical about being in a room together.” These were the words of CEO Janice Chang as she opened our summit of member company leaders this spring, and she was absolutely correct.

 

Over two days together in Philadelphia filled with engaging discussions, panels, and collaborative sessions, we forged new connections, engaged in healthy debate, and identified critical actions to help us in our mission to drive the convergence of clinical research and clinical care for the benefit of patients worldwide.

 

The spirit of collaboration unites us all, and we are grateful for the shared commitment on display during this gathering.

Pint-Sized TransCelerators

 

We had a lot of fun with our youngest TransCelerators at this year's Take Your Child to Work Day!

 

The day was filled with a range of educational activities, including lessons on target selection, a mock clinical trial, and crafting a marketing plan to promote trial results. Events like this help us inspire and nurture the next generation of potential doctors, scientists, nurses, marketers, and more!

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Value, Realized: Cycle Time

Reduced by 20%

 

TransCelerate solutions at work! A sponsor company implemented the TransCelerate Clinical Protocol Template (CPT) across all interventional clinical studies and noted several positive impacts, including significant time savings in protocol development and reduced need for rework.

 

Overall, the implementation has enabled the company's study teams to develop high-quality, streamlined clinical study protocols in less time. The continued maturity of the CPT use resulted in a 21% average decrease in cycle time/effort. Finally, the sponsor company reported that continued implementation of the CPT across new studies has helped tremendously in its pursuit of bringing vital drugs to patients faster.

Learn more

Strategic Programs Launches and Updates

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"Sponsor Experience Implementing Decentralized Clinical Trial (DCT) Elements: DCT Implementation Survey Results" (Modernizing Clinical Trial Conduct initiative) paper describes collective experiences deploying decentralized clinical trial elements beyond the COVID-19 pandemic– including the associated challenges and lessons learned, and the factors that made implementation successful.

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"Assuring Audit and Inspection Readiness—Considerations for the Use of RWD and RWE in Regulatory Decision-Making" (Real-World Data (RWD) initiative) paper was developed to clarify the type of documentation regulators may obtain or request from data providers and sponsors to support using RWD and Real-World Evidence (RWE) to inform regulatory decision-making.

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Release 3.0 of the Study Definitions Repository and Unified Study Definitions Model (USDM) (Digital Data Flow initiative) is now available. This release's goals include expanded protocol digitalization with full protocol coverage in the USDM 3 model, enhanced downstream connectivity, alignment with ICH M11, and exploration of using the CDISC CORE engine for USDM conformance checks.

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"The Digital Health Landscape Assessment" and the "Survey of Digital Health Use" (Interpretation of Pharmacovigilance Guidances & Regulations initiative) are two solutions that aim to provide a view of the Digital Health PV ecosystem from the perspectives of regulators, external bodies, and member companies.

Mark Your Calendars

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TransCelerate Webinar

11 July: Vulcan UDP (Utilizing the Digital Protocol): Collaborating to Accelerate ICH M11 and End User Value 

Interested in joining the TransCelerate Awareness & Implementation community? 

 

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TransCelerate BioPharma Inc., 300 Conshohocken State Rd, Suite 420, West Conshohocken, PA 19428, United States, +1 484-539-1240

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