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:
Good Manufacturing Practices (cGMP): When Do They Apply?
When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:
12 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:
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:
Q&A Part 2 – Gene Therapy Research in the Age of COVID-19
Expert panelists from Advarra’s gene therapy virtual symposium address some of the most popular questions submitted by the audience. Read part 2:
Patient Engagement and the IRB
With increased efforts to engage and include patient and participant communities more closely in research, when does an IRB review become required?