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 Advarr...| Advarra - Advancing Better Research
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule). This blog highlights some of the major proposed changes and how they may impact the clinical research| Advarra - Advancing Better Research
Read the best thought leadership in the clinical research industry from the experts at Advarra| Advarra - Advancing Better Research
Advarra partnered with PreHealth, a brand growth and experience agency, to create Braid, the identity for Advarra’s data and AI engine. To share the story behind the name and brand, we spoke with Laurie Thackeray, Head of Global Marketing at Advarra, and Mike Hartman, Founder and CEO of PreHealth. Here’s what they had to say| Advarra - Advancing Better Research
Advance human health with our global team. Join us to make clinical research safer, smarter, and faster, delivering life-changing therapies worldwide.| Advarra - Advancing Better Research
ICH E6(R3) is here—are you ready? Learn how this major GCP update reshapes clinical trial oversight with risk-based proportionality, quality by design, and regulatory alignment. Discover key actions sponsors must take now.| Advarra - Advancing Better Research
Have questions about Advarra? Whether you're looking for streamlined processes, expert guidance, or advanced technology, our team is here to help.| Advarra - Advancing Better Research
Get resources and best practices for clinical research site, sponsor, and CRO relationships including transparency, feasibility, and more.| Advarra
Get resources and best practices for clinical research financial management including coverage analysis and participant payments.| Advarra
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.| Advarra
Federal requirements have shifted to require most multisite clinical trials to rely on a single IRB (sIRB) for trial oversight.| Advarra
Recent regulations and policies have many institutions establishing policies and processes for working with an external sIRB. Read more:| Advarra
Get resources and best practices for clinical research reporting requirements including common rule, FWA, ALCOA, and more.| Advarra
Get resources and best practices for clinical research operations including site management, workflows, community engagement, and more.| Advarra
Get resources and best practices for clinical research compliance including 21 CFR Part 11, regulatory management, FWA, and more.| Advarra
Learn how Longboat is reimagining critical workflows across sites, sponsors, CROs, and patients.| Advarra
Internal IRB reviews are NOT free, contrary to popular belief. In this blog we outline practical steps for assessing and establishing IRB review cost| Advarra
Find out how the EU AI Act will likely impact clinical research software and systems, and what EU and non-EU entities should do to prepare for compliance.| Advarra
Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.| Advarra
Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources can go, assessing a study’s feasibility is critical for success. Evaluating feasibility elements enable organizations to make informed decisions and allows for seamless execution and reporting of clinical studies. How can your organization utilize feasibility to its fullest extent? Defining| Advarra - Advancing Better Research
This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.| Advarra
Explore key local considerations for developing single IRB policies, and learn how to navigate the challenges- including compliance, ethical standards, and institutional requirements.| Advarra
Ensure GCP compliance throughout your clinical research lifecycle with a comprehensive guide to GxP audits.| Advarra
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.| Advarra - Advancing Better Research
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.| Advarra - Advancing Better Research
The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.| Advarra - Advancing Better Research
