Institutions
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Thinking About the Box: Considerations for Transport of Investigational Products
Ensure safe transport of investigational products with meticulous planning and rigorous procedures to mitigate hazards and uphold biosafety.
Clinical Trial Startup: Insights from the Industry
Clinical research professionals provide relevant insights into challenges and barriers impeding study start up.
The Role of Financial Management and GAAP in Clinical Research
Learn how robust financial practices and a CTMS aligned with GAAP principles can drive sustainable growth and efficiency within an organization.
Unlocking Study Activation: 2023 Study Activation Report
Access the survey report now for current perspectives on study startup activities impacted by rapidly evolving technology and tools.
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.
Best Practices for IRB Review of DCTs: Expert Perspectives
Leverage best practices for IRB review of decentralized trial elements sourced from research community experts.
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.
GxP Best Practices for Safer, Smarter, Faster Clinical Research
Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.
Optimizing Your Human Research Protection Program: The Role of Quality Training
Having a robust human research protection program (HRPP) in place is vital when maintaining compliance and keeping participants safe.
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.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
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