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.
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.
A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator sites, vendors, and internal processes in clinical trials.
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The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.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.”
We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll 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.”
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible
Every site is different. Learn how to meet their unique needs and make workflows and collaboration more efficient in this blog.
During the course of study conduct, most research involving human participants will require some form of planned modification or revision.
Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While