Newsletter | December 5, 2024

12.05.24 -- How Technology Has Changed Computer System Validation

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FEATURED EDITORIAL

How Technology Has Changed Computer System Validation

"The Validation Specialist" Richie Siconolfi explores computerized system compliance in clinical research in this three-part series, beginning with a primer on two things: the predicate rules (regulations), guidance documents, directives, and guidelines; and the scientific method.

INDUSTRY INSIGHTS

Lack Of Uptake By Sponsors Of The Draft FDA Recommendations For PROs In Oncology

This article examines the challenges pharmaceutical companies face in implementing PROs in cancer clinical trials as outlined in the FDA’s draft guidance and suggests ways to overcome these obstacles.

What Universalized Terminology Means For Decentralized Research

Many DCT stakeholders have attempted to release terminology guides as it relates to their own dealings, however, there had never been a wide range of universalized DCT terms until now. 

eCOA Evolution: Have We Overcomplicated It?

eCOA has evolved from simple data collection to complex patient engagement platforms, raising concerns about added complexity. Explore these challenges and tools to simplify this complexity.

How Real-World Data Optimized An Oncology Clinical Trial Protocol

Many challenges in running clinical trials are difficult to prepare for, but some, such as trial enrollment and study operational execution, can be proactively addressed thanks to advances in high-quality RWD.

Data Visualization For Clinical Operations: Transforming Insights Into Action

Data visualization transforms complex clinical trial data into actionable insights, significantly aiding in decision-making and trial management.

Choosing A Digital Health Sensor Partner In Clinical Trials

Explore what your organization should consider when selecting a digital health partner and monitoring solutions for your clinical trial.

Reduce Time, Cost, & Risk With Clinical Study Data Review Software

See how a top 10 global biopharmaceutical company implemented a single data review system to reduce the time, cost, and risk of running its clinical trials while accelerating the time to market.

How Will IQVIA One Home for Sites Simplify Clinical Trial Technology?

IQVIA Technologies leaders answer questions from sponsors, sites, CROs, and tech vendors about their aggregation platform that provides single sign-on across sponsors, studies, and systems.

Break The Contracting Bottleneck To Speed Site Activation

With the appropriate training data, AI has the capability to automate information gathering, document creation, and workflow management.