
Metrics & Benchmarks
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Designing Feasible Protocols with Real-World Data

FDA Approves UCB’s Kygevi for TK2 Deficiency Based on Multi-Study Clinical Program Demonstrating Significant Survival and Motor Gains

Inside the Recruitment Bottlenecks Driving Trial Delays

ACT Brief: Tech-Driven Data Strategies and Long-Term Vaccine Success

Takeda’s Phase III TIDES Trial Confirms Long-Term Efficacy and Safety of Qdenga Dengue Vaccine

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In a decentralized, digitally enabled clinical trial environment, conventional approaches to data analysis are evolving as sponsors utilize technological tools in new ways to ensure compliance with global standards, mitigate risk, and bring life-changing therapies to patients faster.

In this episode of the ACT Podcast, Jeneen Donadeo, executive director of portfolio management at TransCelerate, and Laura Galuchie, senior director and TransCelerate program lead at Merck, discuss the findings from a recent TransCelerate and Tufts CSDD study revealing that nearly one-third of data collected in Phase III trials is non-essential. They explore why trial complexity continues to grow despite industry efforts toward efficiency and share strategies for reducing data burden while maintaining compliance.

In today’s ACT Brief, we explore how Eli Lilly’s orforglipron could become the first oral GLP-1 therapy reviewed under FDA’s new national priority program, and examine emerging regulatory and ethical frameworks shaping bispecific antibody research in oncology.

In this special recap of the most recent SCRS Global Site Solutions Summit, we highlight insights gained from KOLs on-site that emphasize the importance of communication and collaboration between sites and sponsors/CROs.

Explore how AstraZeneca’s immuno-oncology strategy focuses on improving survival in hard-to-treat cancers and moving checkpoint inhibitors into curative-intent settings.

Ethical and regulatory considerations for safeguarding participants in bispecific antibody clinical trials, and best practices designed to optimize their success.

In today’s ACT Brief, we spotlight the industry’s push to reduce site technology burden, AstraZeneca’s broad survival gains from the MATTERHORN trial, and Thermo Fisher’s multibillion-dollar acquisition of Clario to advance AI-driven clinical research.

Learn how perioperative immunotherapy with Imfinzi is addressing long-standing unmet needs in gastric and GEJ cancers and paving the way for a new standard of care.

In today’s ACT Brief, we explore how AstraZeneca is redefining gastric cancer care through the MATTERHORN trial, Phesi’s Gen Li shares how AI and patient data are advancing global trial equity, and FDA unveils new draft guidance streamlining biosimilar development.

Learn how increasing system complexity and patient-facing technologies are creating new burdens for clinical trial sites—and what vendors and sponsors can do to streamline operations and improve support.

Gain insight into how the MATTERHORN trial’s results across PD-L1 subgroups could expand access to immunotherapy and reshape biomarker strategies in early gastric and GEJ cancer treatment.

Discover how the Phase III MATTERHORN trial is redefining outcomes for patients with early-stage gastric and gastroesophageal cancers through the first perioperative immunotherapy regimen to show a survival advantage.

In today’s ACT Brief, we spotlight how new OpenAI collaborations are transforming drug development, how AI is driving smarter site activation in global trials, and how the FDA’s approval of a single-injection Omvoh regimen enhances convenience for ulcerative colitis patients.

Exploring how large-scale patient databases and AI analytics can accelerate site activation, strengthen recruitment, and improve trial design from the start.

Thermo Fisher will integrate OpenAI APIs into its Accelerator Drug Development platform and clinical research business, while Lundbeck deploys ChatGPT across its global workforce to drive R&D and commercial innovation.
























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