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Webinar

What Happens When a Study Fails to Meet Its Recruitment Targets?

Explore IRB considerations for overcoming study enrollment barriers while ensuring risks to participants are appropriately minimized.

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Blog

Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance

A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing deviations in clinical research.

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5 min. read
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Webinar

Best Practices for IRB Review of DCTs: Expert Perspectives

Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.

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Blog

Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate

Understand the significance of HRPP staffing despite an sIRB mandate, and how HRPP staffing maintains ethical research practices.

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3 min. read
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Blog

Beginner’s Guide to Human Research Protection Programs

A robust institutional HRPP plan includes a comprehensive compliance framework and experienced staff focused on protecting research participants.

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5 min. read
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Blog

What is an sIRB and Why Does my Study Need One?

Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.

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6 min. read
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Blog

Public Perceptions of Clinical Trials: A Comprehensive Survey

In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.

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6 min. read
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Webinar

sIRB 101: An Introduction to Relying on an External IRB

Learn the basics of working with an sIRB and gain insights for successful sIRB relationships with external IRB partners.

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Webinar

Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs

Discover strategies for proactively assessing compliance for an FDA Inspection Readiness visit. Address deficiencies and implement corrective actions.

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Blog

Device Risk Determinations for IVD Research

Learn the FDA's investigational device exemption requirements for clinical trials involving investigational in vitro diagnostic devices.

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5 min. read
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Blog

Phases of Clinical Research: A Detailed Overview

Gain a comprehensive understanding of the various phases involved in clinical research, their objectives, and outcomes that ensure safe and effective clinical treatment.

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6 min. read
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Blog

4 Unique Challenges of Oncology Trials

Oncology research is unique in many ways, including the challenges researchers face in conducting cutting-edge trials.

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5 min. read
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