Important Considerations When Developing and Implementing a Clinical Trial –...
Developing and running a clinical trial can be a large undertaking. There are many factors to consider when translating a research question into a full clinical trial, which can be particularly...
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How Emerging Technologies Are Challenging Traditional IRB Oversight
Artificial intelligence (AI), connected wearables, and Software-as-a-Medical-Device (SaMD) are expanding the very definition of a “device.” New technological innovations continue to obscure traditional...
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Considerations for Informed Consent in Clinical Trials Involving Neurologic...
Informed consent is a cornerstone of ethical clinical research. As stated in the Belmont Report, a foundational research ethics document, true informed consent must have three components: information,...
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4 Tips for Managing Protocol Deviations in Cell Therapy Clinical Trials
The FDA recently released draft guidance to help sponsors, clinical investigators and Institutional Review Boards (IRBs) better define, identify and report protocol deviations in clinical trials. By...
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How to Comply with the New NIH Transparency Rules for r/sNA Research
On June 1, 2025, an implementation update from the NIH Office of Science Policy (OSP) took effect. These requirements apply to institutions conducting NIH-funded research involving recombinant or...
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The Flexibility of Reconsent in Clinical Trials
When an IRB determination letter indicates that reconsent is required, it can feel like a rigid mandate that adds to the workload of teams already operating with limited time and resources. Reconsent...
View ArticleInitial IRB Submission: 7 Fundamentals of Success
IRB review and approval are required before a clinical trial can begin. The faster your protocol is approved, the faster you can get to your trial’s starting line. How can you work to get the initial...
View ArticleCritical Questions for Your IRB
Think the IRB review process can’t be easier? Think again. Submitting your protocol to an IRB is the first of many steps in a successful clinical trial. Get it right the first time, and you keep your...
View ArticleConsiderations For Informed Consent In Clinical Trials Involving Neurologic...
By Linda Reuter Informed consent is a cornerstone of ethical clinical research. As stated in the Belmont Report, a foundational research ethics document, true informed consent must have three...
View ArticleAssent: Not just for kids anymore!
Most clinical research professionals are familiar with the concept of assent (in parallel with parental permission) as part of the process of informed consent when conducting clinical research in...
View ArticleBRANY Unveils Protocol Builder® 2.0: The Next Generation of Protocol Writing
AI features simplify research protocol development, ensuring accuracy and compliance. Lake Success, NY – May 22, 2025 – BRANY announces the launch of Protocol Builder® 2.0, an advanced cloud-based tool...
View ArticleWhat is the difference between clinical trial auditing and monitoring?
What is the difference between clinical trial auditing and monitoring? Watch the video to find out more: BRANY Auditing and Monitoring on Vimeo If you want to learn more about auditing and monitoring...
View ArticleSelect Series: Helpful Information from BRANY’s Quality Assurance Team...
Monitoring plays an important role in the oversight of human subject research and compliments the primary investigator’s oversight responsibilities. There are four major goals of monitoring:...
View ArticleSelect Series: Helpful Information from BRANY’s Quality Assurance Team Are...
Ensuring readiness for a successful clinical research audit involves meticulous preparation and attention to detail across several key areas. Quality Assurance (QA) reviews serve as checkpoints to...
View ArticleSelect Series: Helpful Information from BRANY’s Quality Assurance Team...
Is your study’s regulatory binder up-to-date and audit ready? You may have all the IRB submissions and approvals on file along with protocols, IBs, and informed consent forms. But are all the personnel...
View ArticleSeries: Helpful Information from BRANY’s Quality Assurance Team Protocol...
A protocol deviation is any temporary alteration/modification to the protocol and other IRB-approved information relating to the research study, such as the consent form, recruitment materials, and...
View ArticleSeries: Helpful Information from BRANY’s Quality Assurance Team Eligibility...
Today we will be discussing the second topic in the BRANY QA team’s series discussion of common findings from our Quality Assurance Reviews: eligibility criteria. When the BRANY QA team is reviewing a...
View ArticleSeries: Helpful Information from BRANY’s Quality Assurance Team Introduction...
Introduction BRANY’s Quality Assurance team conducts Quality Assurance Reviews of clinical trials across all indications. The purpose of these reviews is to assess compliance with applicable...
View ArticleIs Your Clinical Research Site GCP-Ready?
Essentials for Regulatory Compliance Good Clinical Practice (GCP) guidelines provide an ethical and scientific quality standard for investigators, sponsors, monitors, and institutional review boards...
View ArticleFDA Releases Guidance on Informed Consent
This article reviews the FDA’s recent guidance for informed consent, and what should be included. In August 2023, the FDA released guidance intended to assist institutional review boards (IRBs),...
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