Newsletter | February 7, 2025

02.07.25 -- What Is 'Fit For Use' In AI Models?

TRIAL MONITORING

FDA Provides Updated Draft Guidance To Support E6(R3)

Get a quick but thorough understanding of "E6(R3) Good Clinical Practice: Annex 2."

QT Monitoring Impacts More Than Just Cardiac Health

Achieve earlier detection of potential adverse cardiac events and refine patient selection for future trial phases by implementing advanced QT monitoring tools.

CLINICAL DATA MANAGEMENT & ANALYTICS

What Is 'Fit For Use' In AI Models?

The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.

Trends In Clinical Trials In 2025: Navigating A Transformative Landscape

In 2025, it is likely the clinical trial landscape will be shaped by advancements in artificial intelligence (AI), evolving recruitment strategies, and a renewed focus on equitable access.

The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality

Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.

The Benefits Of Next-Generation SAAS Have Arrived

See how life science companies are using software as a service (SaaS) to bring new benefits to study startup, data collection, and more with this short blog.

Are You Leveraging All Of Your Clinical Data?

To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. Learn how you can better utilize your trial data and achieve greater insights.

Overcoming Issues Of Non-Enrolling Sites In Clinical Trials

Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.

TrialKit: Your Comprehensive Solution For Non-Interventional Studies

In the ever-evolving landscape of non-interventional clinical studies, the demand for a platform that seamlessly adapts to diverse and increasingly complex research methodologies is critical.

Standardized Data In One Place

Simplify clinical trial data management with Signant’s Clinical Data Hub. Harness machine learning to aggregate diverse data sources, streamline analysis, and unlock timely, actionable insights.

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