Register

Featured Content

Staying Connected and Compliant: Reimagining Clinical Trials with Longboat
Few technologies have radically changed the way we do business as electronic workflows. Today, projects can be edited by multiple... The post Staying Connected and Compliant: Reimagining Clinical Trials with Longboat appeared first on Advarra.
Budgeting for IRB Review: A Guide for HRPP Leadership
At institutional research programs around the U.S., there exists a pervasive myth: internal institutional review board (IRB) reviews are free.... The post Budgeting for IRB Review: A Guide for HRPP Leadership appeared first on Advarra.
Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The European Parliament recently adopted... The post Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research appeared first on Advarra.
Good Manufacturing Practices: When Do They Apply?
In the development of a new drug, when do current Good Manufacturing Practices (cGMP) regulations apply? Clinical project teams often struggle with answering this question. In this article, we will discuss the US Food and Drug Administration (FDA) expectations for the application of cGMP to investigational drugs. The post Good Manufacturing Practices: When Do They Apply? appeared first on Advarra.
Developing a Data-driven Feasibility Process
Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources can go, assessing a study’s... The post Developing a Data-driven Feasibility Process appeared first on Advarra.
The Regulatory Binder Checklist For Clinical Trial Sites
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents;... The post The Regulatory Binder Checklist For Clinical Trial Sites appeared first on Advarra.
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their... The post The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering appeared first on Advarra.
Navigating Local Considerations When Developing sIRB Reliance Policies
In recent years, the use of single institutional review board (sIRB) review has gained significant traction in the world of... The post Navigating Local Considerations When Developing sIRB Reliance Policies appeared first on Advarra.
GxP Audits Guide for Successful Clinical Trials
A well-designed GxP audit program, in addition to satisfying the regulatory requirement of sponsor oversight, allows for early detection of... The post GxP Audits Guide for Successful Clinical Trials appeared first on Advarra.
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... The post Impact of sIRB Mandates on Study Teams appeared first on Advarra.