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Understanding FDA’s 2024 Draft Guidance on DMCs
Clinical trials are the cornerstone of medical advancements, but ensuring their integrity and safety requires meticulous oversight. Data monitoring committees...
The post Understanding FDA’s 2024 Draft Guidance on DMCs appeared first on Advarra.
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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.”
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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...
The post SAE Reporting and the IRB: Adverse Events in Drug Studies appeared first on Advarra.
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Checklist to Reduce Burden on Sites and Patients
The site-sponsor relationship continues to become more important day by day. With trial complexity increasing, site staff availability stretched thin,...
The post Checklist to Reduce Burden on Sites and Patients appeared first on Advarra.
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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...
The post Enhancing User Experience, Security, and Compliance with Single Sign-on appeared first on Advarra.
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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....
The post IRB Review of Changes to Previously Approved Research appeared first on Advarra.
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Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance
Sponsor and contract research organization (CRO) team members such as clinical research associates (CRAs), study managers, and startup specialists collaborate...
The post Clinical Trial Efficiency: Top Risk Indicators and Solutions for Site Performance appeared first on Advarra.
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Optimizing Site Initiation Timelines Through Centralized Processes
In clinical trials, time is both an ally and an adversary. Efficient site initiation can make or break the success...
The post Optimizing Site Initiation Timelines Through Centralized Processes appeared first on Advarra.
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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...
The post mRNA Cancer Vaccines and Therapies: An Overview appeared first on Advarra.
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Implementing eSource: A Guide for Operations and Technology Roles
There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data...
The post Implementing eSource: A Guide for Operations and Technology Roles appeared first on Advarra.