Consulting
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:
Coverage Analysis: Standard of Care vs. What Medicare Covers
Learn more about coverage analysis, the process to determine if an item or service is part of a patient's standard of care or covered by Medicare.
Certificates of confidentiality and unexpected complications for pragmatic clinical trials
Judith Carrithers co-authored the article "Certificates of confidentiality and unexpected complications for pragmatic clinical trials" in Learning Health Systems.
Fireside Chat: The Future of Clinical Trials and Site Engagement
The COVID-19 pandemic has proven that research can be done more efficiently. To make these efficiencies sustainable, the sites’ perspective must be considered. Sponsors, CROs, and sites should engage early ...
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:
Fitting Your Needs: Pandemic-Proofing Protocols
The COVID-19 pandemic forced organizations to adjust to continue high-quality research, positioning research to be more patient centric and streamlined.
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.
Human Research Protection Program Services
Download our info sheet to learn how Advarra can revitalize your human research protection program (HRPP) with customized consulting support
7 Staff Augmentation Resources to Help Your Site Restart Research
Advarra offers a number of services to help you restart your short- or long-term research activities, such as Staff Augmentation.
For Sponsors and Sites, the Research Restart Effort Begins With Communication
The global pandemic has changed the way we think about research. Sponsors should consider how the “new normal” will impact sites and current studies.
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: