Stay up to date on all TransCelerate happenings!

April 9, 2024

 News At-a-Glance

TransCelerate kicked off 2024 with an exciting announcement that Gilead Sciences has joined us as our newest Member Company. 

Allison Cuff Shimooka joined our organization last year and serves as the Chief Operating Officer. She continues to assume the responsibility in 2024 for translating TransCelerate’s strategic vision into operational plans in close partnership with the leadership team, Member Companies, and Board of Directors.

Earlier this year, TransCelerate announced the release of our highly anticipated 2023 Annual Achievements Report! This report is a testament to our commitment to advancing the landscape of clinical trials and driving impactful change within the ecosystem. 

Read about our accomplishments in 2023, goals for 2024, and TransCelerate’s unwavering commitment to patients to drive the convergence of clinical research and clinical care. 

In honor of International Women's Day 2024, TransCelerate hosted a special panel discussion for thought-provoking conversations from our panelists Rob Goodwin (Pfizer), Esther Krofah (Milken Institute Health), Joni Rutter (NCATS/NIH),  Janet Woodcock (formerly of the FDA), and Janice Chang (TransCelerate) who shared their insights into how they inspire and foster a culture of inclusion. 

To continue honoring International Women's Day, TransCelerate captured a variety of women leaders from our member companies who were asked, "How will you inspire inclusion?"

Since 2012, TransCelerate has designed, developed, and delivered 525+ solutions and implementation tools to the biopharma R&D ecosystem. 

A sponsor company used parts of the Patient Protocol Engagement Toolkit (P-PET) for patient and caregiver interviews to obtain patient insights for a study protocol. Ultimately, the patient experience interviews informed the sponsor’s development program by helping the study team gain new insights into symptomology from understanding the disease and treatment burden.

Strategic Programs Launches and Updates

The Signal Management-Intelligent Automation Opportunities for Signal Detection (Intelligent Automation Opportunities in Pharmacovigilance Initiative) identifies how a representative sampling of major pharmaceutical companies currently uses intelligent automation for various PV process steps within a generic signal management framework, thereby raising awareness as to the potential opportunities for the broader industry in this area.

The Study Participant Feedback Questionnaire (SPFQ) FAQs (Patient Experience Initiative) were developed to support adopters/potential adopters of SPFQ implementation. They offer a collated list of questions and answers structured and categorized across key content topics defined in the SPFQ Implementation User Guide. 

TransCelerate has partnered with the Association of Clinical Research Organizations (ACRO) to release a new infographic that features the key changes to risk management in ICH E6 (R3) between Version 2 and 3.

The published paper from Therapeutic Innovation & Regulatory Science, “Regulations Governing Medicines for Maternal and Neonatal Health: A Landscape Assessment,” (Interpretation of Pharmacovigilance Guidances & Regulations Initiative) summarizes key findings from a landscape assessment of regulations and guidances on the use of medicines in pregnancy and breastfeeding issued by Health Authorities in various territories (including the Americas, Europe, Africa, and Asia Pacific).

A recent article in Clinical Leader shares how TransCelerate and CDISC have collaborated to create a common digital language for protocols that may be applied consistently across organizations with the Digital Data Flow (DDF) Initiative. The program of work aims at automating the exchange of protocol information across the study life cycle.

The release of the Clinical Template Suite (CTS) (Clinical Content & Reuse (CC&R) Initiative) marks the 10th anniversary of the first release of the Common Protocol Template. Today, TransCelerate offers a suite of templates and implementation tools.

Mark Your Calendars

Industry Event

16-17 April: Data Driven, Hybrid & Full Decentralized Clinical Trials Conference

Industry Event

24-25 April: CDISC Europe Interchange

TransCelerate Webinar

16 May: Pharmacovigilance Agreement Solutions You Didn’t Realize You Needed

TransCelerate Webinar

6 June: Is Your RWD Regulatory Ready? Considerations When Preparing RWD for a Regulatory Submission 

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