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Case Study

Ensuring Recruitment and Compliance Success of an Evolving Rare Neuromuscular Disease Study

Find out how the Longboat Platform ensured not only recruitment success, but site and participant support and compliance.

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Webinar

Rare and Orphan Diseases in Regulated Development

In this webinar, gain an in-depth understanding of regulatory and clinical development challenges for rare/orphan diseases.

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Blog

Beginner’s Guide to Single IRB Mandates

More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.

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Blog

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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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 Now, FDA provides draft guidance on ethically including kids in trials.

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4 min. read
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Blog

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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4 min. read
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E-Book

Setting Yourself up for Success During Investigator-initiated Trials

This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.

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Webinar

Addressing Decentralized Pre-Enrollment Challenges for Sites and Site Networks

Learn key processes and tools for your team to use to ensure your organization operates at peak performance.

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Webinar

Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software

Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.

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Case Study

Yale Enhances Patient Safety, Billing Workflows with OnCore and EMR Integration

Read how Advarra created an integration connecting the OnCore CTMS with Yale’s EMR system to support a compliant billing process.

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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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5 min. read
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