
Metrics & Benchmarks
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FDA Approves Komzifti for NPM1-Mutated AML Based on Positive Phase I/II KOMET-001 Trial Data

Proactive Planning is Key to Mitigating Study Rescue

ACT Brief: Site Satisfaction, eSource Data Transfers, and Gilead HIV Trial Results

Gilead’s Single-Tablet Bictegravi/Lenacapavir Regimen Shows Positive Phase III ARTISTRY-1 Results in Virologically Suppressed Adults with HIV

Advarra and IgniteData Partner to Streamline eSource-to-EDC Data Transfer

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Melissa Hutchens, vice president of research & benchmarking at WCG, and Jimmy Garza, senior director of clinical operations at Bayer, discuss findings from the latest WCG CenterWatch Global Site Relationship Survey, revealing a decline in overall site satisfaction. They explore key drivers behind this trend, including technology usability, communication gaps, and limited site input in protocol design, and share actionable approaches to strengthen sponsor-site partnerships and improve study execution.

As biotechs expand their outsourced clinical operations, adopting a CTMS is becoming essential to ensure CRO oversight, regulatory compliance, and real-time visibility across trials and portfolios.

In Vibrance-2, oral alixorexton significantly improved wakefulness and reduced excessive daytime sleepiness with a favorable safety profile, positioning the OX2R agonist for rapid advancement into Phase III trials.

In today’s ACT Brief, we look at how artificial intelligence is reshaping drug development decisions across pharma, discuss evolving sponsor oversight in site selection and protocol design, and review the FDA’s decision to update menopausal hormone therapy labels for clarity and safety.

Learn how organizing data assets, activating nonresearch HCPs, and building referral pathways with compliant remuneration can convert identified patients into enrolled participants.

In 2025, both big pharma and biotech are redefining decision-making as AI, real-world evidence, and flexible deal structures accelerate drug development, flatten organizational silos, and close the innovation gap across the life sciences ecosystem.

In today’s ACT Brief, we look at how adaptive trial models are reshaping precision medicine, new data showing Wegovy’s impact on liver health, and Eli Lilly’s latest collaborations advancing genetic and RNA-based therapies.

Gain insight into why sponsors are taking a larger role in site selection and CRO oversight using robust data to validate feasibility before launch.

Novel trial designs are reshaping clinical development by improving efficiency, reducing redundancies, and accelerating timelines toward a new era of precision medicine.

Cogent Biosciences’ combination therapy cut the risk of disease progression or death by 50% compared to sunitinib alone, with a favorable safety profile and plans for FDA submission in early 2026.

In today’s ACT Brief, we explore how AI and tokenized data are improving patient-protocol matching, highlight Caplyta’s new FDA approval for major depressive disorder, and review the FDA’s expansion of its National Priority Voucher program.

Discover why strategies must vary by indication and geography and how data-driven matching with supported referrals can outperform site expansion and generic advertising.

Caplyta (lumateperone) demonstrated significant symptom improvement and favorable tolerability as an add-on treatment for adults with major depressive disorder, supported by two pivotal Phase III trials and long-term extension data.

In today’s ACT Brief, we explore how real-world data can improve protocol design and feasibility, highlight new findings from Novo Nordisk’s oral semaglutide program, and review Eli Lilly’s promising Phase II results for a novel amylin receptor agonist.

Understand how combining proprietary and real-world datasets with tokenization enables accurate protocol matching while maintaining privacy and compliance.
























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