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Home » Newsletters » CenterWatch Weekly

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October 2, 2023

View Archived Issues

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FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More

Biomarkers Pinpoint Immune Dysfunction in Patients with GVHD, FDA Guidance Says

Developers of graft-versus-host disease (GVHD) therapies can design trials based on a new FDA draft guidance that focuses on using biomarkers to identify individual patients’ specific immune dysfunction rather than suppressing the entire immune system. Read More

Drug & Device Pipeline News

This week’s Pipeline features a phase 1 trial approval for Alpha-1 antitrypsin deficiency, trial initiations for spinal muscular atrophy, spinal cord injury and obstructive sleep apnea, and another FDA approval for blockbuster diabetes drug Jardiance. Read More

Upcoming Events

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    MAGI@home Clinical Research Conference 2023

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    2023 WCG Patient Forum

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    FDA in 2024: What to Expect in an Election Year

Featured Products

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

  • Best Practices for Clinical Trial Site Management

    Best Practices for Clinical Trial Site Management

Featured Stories

  • Donna Snyder

    New WCG Executive Physician Outlines Goals for Clinical Research

  • Hand Shake at Meeting

    Partnership to Bolster Trials in Low Resource Regions Kicks Off

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    Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

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    Ask the Experts: Monitoring

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
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