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.
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.
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.
What is a Data Monitoring Committee?
In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.
GxP Best Practices for Safer, Smarter, Faster Clinical Research
Uncover key regulations and insights regarding GxP in pharmaceuticals, medical devices, and clinical research.
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.
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.
Public Perceptions of Clinical Trials: A Comprehensive Survey
In a complex and competitive climate, we sought the understand existing perceptions surrounding clinical research trials.