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Medicare Coverage Analysis Worksheet

Determine whether your trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.

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Your Guide to sIRB Mandates

sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.

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Why Keep HIPAA Separate from the Informed Consent Form

HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.

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Blog

Regulatory Trends in Cell and Gene Therapies

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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 Now, FDA provides draft guidance on ethically including kids in trials.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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Blog

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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Blog

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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Blog

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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Blog

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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Blog

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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Blog

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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