Planning for Complex Change at Your Organization
The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational […]
Research Compliance
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Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
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.”
Reporting to the IRB: Investigator Noncompliance
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.”
SAE Reporting and the IRB: Adverse Events in Drug Studies
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible
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.
mRNA Cancer Vaccines and Therapies: An Overview
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While
Implementing eSource: A Guide for Operations and Technology Roles
Implementing eSource can streamline data collection for research sites, but ensuring data integrity, compliance, and accuracy is essential for successful adoption and reliable results.
How Sponsors and Sites Work Together to Improve Protocol Compliance
Sites and sponsors can adopt strategies to reduce quality issues and avoid FDA warning letters by improving collaboration, training, and resource access.