Clinical Research
Good Manufacturing Practices: When Do They Apply?
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.
Key Items Auditors Look for When Reviewing an Investigator Site File
Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:
Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies
What do the regulations say about unanticipated device effects and IRB reporting? In this blog, Advarra addresses unique requirements for medical device studies.
Reporting to the IRB: Investigator Noncompliance
Find out what the regulations say about reporting noncompliance to the IRB and how IRBs have addressed the undefined gray areas.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
Reducing Site Burden Throughout Study Startup
Learn strategies to streamline workflows across sites and sponsors, and explore success stories on how to reduce site burden.
Embracing Changes to the Clinical Research Workforce
In this episode, we discuss workforce challenges in the clinical research industry and the impact of the great resignation.
Your Guide to sIRB Mandates
sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.
3 Essential Elements of Change Management Within Clinical Research Operations At Your Research Site
Learn how to make sure the three critical factors for productive change are equally balanced considerations of your change management efforts.
Making a Case for Interim HRPP Staffing
Don't wait to fill an HRPP position until it's too late. Understand the risks of an understaffed HRPP and how interim staffing support can help. Read more:
Introducing Fireside Chats: Conversations On Burning Research Topics
Advarra is excited to introduce Fireside Chats, a series of virtual conversations. Fireside Chat is an informal conversation between an Advarra representative, and a clinical research thought leader.
Q&A Part 1 – Gene Therapy Research in the Age of COVID-19
Panelists from Advarra’s inaugural virtual symposium participated in a Q&A session to address questions submitted by the audience. Read part 1:
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