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Blog

GxP Audits Guide for Successful Clinical Trials

Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.

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6 min. read
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Blog

Understanding FDA’s 2024 Draft Guidance on DMCs

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

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6 min. read
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Webinar

Striking the Balance: Ethics, Inclusion, and Vulnerability in Research

Explore the ethical tensions between including under-represented communities and ensuring vulnerable participant populations are appropriately protected.

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Blog

SAE Reporting and the IRB: Adverse Events in Drug Studies

Explore the basics of SAE reporting to the IRB for drug studies. Learn about reportable events, FDA regulations and guidelines, and how to assess AEs.

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6 min. read
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Blog

Enhancing User Experience, Security, and Compliance with Single Sign-on

As technology evolves and the industry streamlines research workflows, implementing SSO can lead to significant improvements in both user experience and security.

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5 min. read
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Webinar

Navigating sIRB Complexities: An Interactive Session

Join us as we share insights, strategic priorities, and guidance for preparing your institution for sIRB mandates.

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Webinar

Sponsors: Are Your Sites Ready for an FDA Inspection?

Learn a comprehensive overview to prepare sponsors and sites for an FDA inspection.

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Blog

IRB Review of Changes to Previously Approved Research

Make sure you know the IRB review requirements for amendments involving changes to IRB-approved protocols and other study modifications.

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5 min. read
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Blog

Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance

Monitor four critical metrics across your sites to prevent persistent challenges to clinical trials

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Blog

Our OnCore CTMS Vision: Building a Foundation for Success

More than two decades ago, we created OnCore CTMS. What do we have in store for the future?

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5 min. read
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E-Book

Making Good Clinical Practice More Understandable

This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.

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Blog

Unpacking The Role of a Right-Sized QMS in Study Startup

Discover the crucial role of a customized QMS in streamlining and optimizing study startup processes.

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4 min. read
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