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Ace Your Next FDA Inspection
Discover valuable insights and expert guidance on navigating FDA inspections in clinical research.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.
A Checklist for Optimizing Clinical Trial Study Startup Activities
This checklist outlines key milestones and considerations for sites and sponsors in the clinical trial study startup process.
Utilizing eRegulatory Integrations to Expedite Regulatory Workflows
Learn how key eRegulatory integrations like email, local and central IRBs, and Clinical Trial Management Systems can accelerate study start up, increase compliance, and improve regulatory workflows.
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Clinical Endpoint Adjudication Committees: Not Just for “Endpoints”
This blog outlines critical events where EACs are used to look at more than just “endpoints” in clinical research.
Impact of sIRB Mandates on Study Teams
Much has been written about the impact of single institutional review board (sIRB) mandates on local IRBs and human research...
eClinical Regulatory Trends Impacting Clinical Research
Understand current regulatory trends in clinical research and how it will shape the industry moving forward.
What is a Data Monitoring Committee?
In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.
Understanding Various Site Use Cases for eSource and EDC
Utilizing a comprehensive, site-centric eSource or electronic data capture (EDC) platform can streamline a site’s data capture, management, and compliance.
5 Tips for Successful Project Management in Clinical Research
Learn how to improve project management practices at your clinical research organization and reduce the risk of complications on clinical trials.
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