Clinical Trial Budget Negotiations: A View From Each Side
Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.
Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.
Medicare Coverage Analysis outlines criteria to determine coverage eligibility, guiding trials through compliance with CMS guidelines for billable services.
Antibiotic resistance is an emerging problem. Some have argued bacteria are developing antibiotic resistance faster than we can research, develop,
A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents;
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.
Training is crucial for changing employee behavior, but not every issue requires it. Identifying when training is necessary can enhance effectiveness and accountability.
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.
The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational
Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements without disrupting daily operations.
The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.
In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”