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; […]
Research Operations
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.
Strategic Training: Navigating Organizational Challenges
Training is crucial for changing employee behavior, but not every issue requires it. Identifying when training is necessary can enhance effectiveness and accountability.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements without disrupting daily operations.
The Value of Continuity: Program-level Data Safety Monitoring Boards
In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. One crucial aspect of
Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.
Checklist to Reduce Burden on Sites and Patients
Every site is different. Learn how to meet their unique needs and make workflows and collaboration more efficient in this blog.
Enhancing User Experience, Security, and Compliance with Single Sign-on
Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security
IRB Review of Changes to Previously Approved Research
During the course of study conduct, most research involving human participants will require some form of planned modification or revision.
Optimizing Site Initiation Timelines Through Centralized Processes
A centralized CTMS team streamlines trial initiation by uniting resources, ensuring data accuracy, and reducing bottlenecks for efficient site startup.