The Value of Clinical Research
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies.
clinical research
Good Manufacturing Practices: When Do They Apply?
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.
Key Items Auditors Look for When Reviewing an Investigator Site File
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.
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.”
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Your Guide to sIRB Mandates
In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
3 Essential Elements of Change Management Within Clinical Research Operations At Your Research Site
The key to effective, productive change within a research institution lies at the nexus of people, process, and technology.
Making a Case for Interim HRPP Staffing
As much as we hate to admit it, many of us have been there…that moment when we suddenly realize “Oh no. I need to fill an HRPP position YESTERDAY. Help!”
Introducing Fireside Chats: Conversations On Burning Research Topics
Advarra is excited to introduce Fireside Chats, a series of virtual conversations discussing current issues in clinical trials. Each Fireside Chat brings together perspectives from across the research community, enabling real-time discussion of contemporary challenges and potential solutions to help make research altogether better.
Q&A Part 1 – Gene Therapy Research in the Age of COVID-19
In Advarra’s inaugural virtual symposium, experts from industry and academia met to discuss the unique challenges gene therapy research poses for research sites, sponsors, CROs, and study participants.
Q&A Part 2 – Gene Therapy Research in the Age of COVID-19
In Advarra’s inaugural virtual symposium, industry and academic experts discussed overcoming obstacles and optimizing study startup in gene therapy research. They respond to more popular Q&A topics here.