The Importance of a Large Network of KOLs for DMCs
In the complex landscape of clinical trials, the data monitoring committee (DMC) serves as the cornerstone at the intersection of […]
Research Compliance
The Evolution of Clinical Quality: Key Considerations from ICH E6 R3
The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of
Strategies For Efficient Clinical Trial Budget Management
Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not
Diversity, Equity, and Inclusion in Clinical Research
Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all
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.
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
Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.
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 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
Navigating Local Considerations When Developing sIRB Reliance Policies
Implementing an sIRB process requires addressing unique local considerations, from consent requirements to cultural nuances, ensuring a streamlined yet ethical review process.
GxP Audits Guide for Successful Clinical Trials
A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator sites, vendors, and internal processes in clinical trials.
Impact of sIRB Mandates on Study Teams
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.