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Blog

Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials

Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.

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FDA’s September 2022 NPRMs: What They Mean for Academia and Industry

FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.

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Modernizing Site Feasibility and Selection

An important decision impacting a multi-faceted study startup process is determining which sites to partner with for study conduct.

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Unpacking IRB Innovations for Decentralized Clinical Trials

Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.

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How Paper and Electronic Source Data Meet ALCOA-C Principles

ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?

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Strategies for Successful Site Selection in Clinical Trials

While clinical trial site selection aids in a trial’s success, it’s critical to maximize the study's time, resources, and funds.

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Keys to Unblocking the Innovation Bottleneck in Research

As the clinical trial industry has evolved in the past decade, it’s invited more complexity into operations and workflows.

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Informed Consent Writing Tip Sheet

Informed consent is a centrally regulated protection for research participants. Learn the regulatory requirements for providing it. 

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How the IND 30-day Hold Impacts Clinical Trial Activities

Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.

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Streamline Study Startup with Improved Site Selection & Feasibility

Identifying the best prepared and performing sites for a study is essential to success. Explore strategies to improve site selection and feasibility.

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Scale Your Training Program: Three Successful Models

Finding the best training solutions begins with understanding your organization’s training needs.

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Beginner’s Guide to 21 CFR Part 11 Compliance

FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.

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