Clinical Research
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?
Safety Precautions for Laboratory Research With COVID-19 Specimens
The pandemic has brought biosafety to the spotlight. This blog discusses guidelines and safety precautions for handling COVID-19 specimens.
Trial Design in the Time of COVID-19: Complex and Efficient
Complex trial designs can eliminate less-promising investigational treatments quickly to speed development, but they remain under-utilized. Read more:
Clinical Trials Day: Thanking the Unsung Heroes
On Clinical Trials Day, now more than ever, it’s important to recognize and thank those unsung heroes at the focal point of research: research sites and institutions. Read more: