Newsletter | March 1, 2024

03.01.24 -- The FDA Speaks Up For Quality Management: Must They Beg?

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TRIAL MONITORING

The FDA Speaks Up For Quality Management: Must They Beg?

Guest Column | By Penelope Przekop, MSQA, RQAP-GCP

The FDA's quality by design (QbD) and risk-based monitoring (RBM) messaging began more than 10 years ago with their guidance on RBM. Eleven years, five total related key guidance documents (listed below), and one global pandemic later, why aren’t we moving forward at more than a snail’s pace? 

Lowering TMF Risks: Real-World Use Cases And Lessons Learned

Webinar | Phlexglobal

Watch as TMF experts share insights from actual customer engagements and pragmatic tips on how companies large and small have reduced TMF risk with less effort.

Harnessing The Power Of Real-World Data In Clinical Trial Planning

Article | Citeline

As the availability of RWD grows, it creates opportunities for sponsors to use true patient insights to support their clinical strategy and bring treatments to patients in need.

CLINICAL DATA MANAGEMENT & ANALYTICS

9 Ways Unified Cloud Platforms Solve Data Challenges In Rare Disease

Guest Column | By Venu Mallarapu

A unified clinical data cloud platform is a data and analytics platform that contains a data hub to aggregate clinical data from multiple data sources and in multiple formats — and it could be the cure for disordered rare disease data.

AI Without The Hype: Realizing High-Value Business Transformations

Article | Sikich

Read this high-level summary to better understand how artificial intelligence can improve product quality, accelerate decision-making, reduce operational costs, and enable preventive maintenance services.

How Vanguard Clinical Harnesses CDMS/EDC For Faster Results

Case Study | Medrio

Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

Industry-Leading IRB Tech Platform For Predictable Results

Brochure | Advarra

Discover a new way to streamline document management and guarantee compliance with regulatory standards, providing a robust and user-friendly solution for optimizing research processes.

Driving Success In Dermatology Drug Development

Brochure | IQVIA Biotech

Our dedicated teams are led by in-house, board-certified dermatologists who have decades of experience conducting early- and late-phase studies. Download the available brochure to learn more.

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