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Webinar

Decentralized Clinical Trials Involving Biologics: Unique Challenges

Find out what FDA says about decentralized clinical trials and biologics, and what this means in practice.

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Webinar

From Simulation to Success: Stress Testing Your Inspection Readiness

Upcoming: October 15

Gain expert insights, best practices, and strategies to navigate FDA inspections with confidence.

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Webinar

Medicare Coverage Analysis in Oncology Trials

This webinar will cover the overall benefits of performing a Medicare coverage analysis, including important criteria to consider.

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Webinar

Overseeing and Operationalizing Patient Recruitment Across Study Stakeholders

This webinar for sponsors and CROs will tackle the most pressing challenge in clinical research: achieving enrollment targets on time.

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Blog

Good Manufacturing Practices: When Do They Apply?

Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.

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3 min. read
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White Paper

Conducting Research With CAR T Cells

This white paper is a guide for research professionals looking to conduct CAR T cell studies for the first time, as well as for those seeking to expand their existing portfolio.

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White Paper

4 KPIs Clinical Research Study Managers Can Master

This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.

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E-Book

Single IRB Review: Tips for Sponsors and CROs Working with Institutional Sites

This eBook provides a toolkit to understand the institutional review board's role when sIRB review is utilized.

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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

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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Webinar

Not if, but When: A Study Manager’s Guide to Adaptability and Incoming Trends

Dive into achieving critical milestones across study startup, conduct, and close out that every project manager should optimize.

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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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