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Blog

The Regulatory Binder Checklist For Clinical Trial Sites

This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.

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5 min. read
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Blog

The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.

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7 min. read
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Webinar

The Importance of Strategic Planning for Long-term Training Success

Explore key strategic planning actions to foster a proactive mindset when designing training and documentation.

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Blog

Strategic Training: Navigating Organizational Challenges

It’s important to define what falls into training and what doesn’t. The key is to know what the training is intended to accomplish.

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4 min. read
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Blog

Key Items Auditors Look for When Reviewing an Investigator Site File

Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:

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6 min. read
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Blog

Planning for Complex Change at Your Organization

Navigate the ever-changing landscape of innovation and technology in clinical operations by discovering strategies to help your organization.

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5 min. read
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Blog

Interim Staffing: Reinvigorating Your Human Research Protections Program

Uphold research compliance best practices with an innovative approach to HRPP.

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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Understanding FDA’s 2024 Draft Guidance on DMCs

Find out about the FDA current views regarding DMCs and the 2024 draft guidance’s implications for clinical trial sponsors.

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Webinar

Inside Study Activation: Budgeting Takeaways

Learn how sites, sponsors, and CROs can work together to help study activation, specifically within budgeting and contracting.

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Blog

Reporting to the IRB: Investigator Noncompliance

Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.

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3 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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