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Home » Newsletters » CenterWatch Weekly

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February 6, 2023

View Archived Issues

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Survey Outlines Site Challenges, Successes on Diversity

With regulators and industry focused on diversity action plans, diversity, equity and inclusion (DE&I) is poised to be a huge priority this year. A recent survey reveals what is and isn’t working for sites on diversity tactics and how sponsors can best lend a hand. Read More
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Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Regardless of size, sites can implement many patient-centric changes without significant costs, and inexpensive ones can actually have a very positive impact, according to DM Clinical, a U.S. site network that’s earned praise for its lower-cost, data-driven approach to putting patients first. Read More

Industry Briefs

FDA Guidance Allows Alternative Data Sources for External Control Arms

The FDA says trial sponsors and investigators may use patient-level data from other trials and/or real-world data (RWD) sources as an external control arm in a new draft guidance. Read More

FDA Provides Draft Guidance on Early Lyme Disease Drug Development

A new FDA draft guidance for sponsors developing drugs to treat early Lyme disease focuses on trial designs for treatment of erythema migrans, a rash that often appears as one of the first symptoms in the disease’s early stages. Read More

FDA FY 2021 Postmarketing Report Shows Sponsor Compliance Lagging

Sponsors still are falling behind in their postmarket reporting, according to the FDA’s yearly update on progress of postmarketing requirements/commitments. Read More

Industry Nonprofit Issues Standards for Sharing Clinical Research Data

In the latest push for data interoperability in drug research, the Pistoia Alliance, a nonprofit aimed at encouraging collaboration among industry stakeholders, has published a guide for data standards that would make research data shareable among sponsors, clinical trial sites and regulators. Read More

Drug & Device Pipeline News

Thirty-two drugs and devices were approved or entered a new trial phase last week. Read More

Research Center Profiles

Research Center Profiles are free to use and provide comprehensive listings of hundreds of institutional and independent sites. Read More

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

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    Survey Outlines Site Challenges, Successes on Diversity

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    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

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

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