Clinical Research

Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.

sIRB regulations and policies have been announced and implemented to help address the challenges of conducting clinical trials involving multiple research sites.

Learn how to make sure the three critical factors for productive change are equally balanced considerations of your change management efforts.

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:

When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:

Ensure your ISF is complete and avoid findings with these examples of specifically what auditors/inspectors look for during an audit. Read more:

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.

Panelists from Advarra’s inaugural virtual symposium participated in a Q&A session to address questions submitted by the audience. Read part 1:

Expert panelists from Advarra’s gene therapy virtual symposium address some of the most popular questions submitted by the audience. Read part 2:

With increased efforts to engage and include patient and participant communities more closely in research, when does an IRB review become required?