Accelerating the Recovery – Design and IRB Review of Safety Monitoring Plans During COVID-19
How do remote visits and data collection impact participant monitoring? What techniques will satisfy the regulatory obligation to conduct safety and data monitoring in this new remote research world?
How Staff Augmentation Services Helps Centralize Site Services
Recently, an Advarra/Forte customer utilized the Staff Augmentation Services to assist on a financials roll-out, including centralizing financial services.
Vendor Qualification vs Requalification Audits: What’s the Difference?
When supporting vendor qualification and management programs, there are different audits to consider. This article defines the differences and how to identify vendors with potential risk for your program.
Ensuring Quality in Risk-Based Monitoring and Data Protection
Protecting participant data is of the utmost importance in clinical research. This article breaks down risk-based monitoring, as well as other data protection terms falling underneath it.
Coverage Analysis: Standard of Care vs. What Medicare Covers
A patient’s standard of care refers to an item or service done as part of their routine care. To address additional assessments outside the participant’s SOC, a coverage analysis is necessary.
Adapting to the Present and Striving for the Future at the AACI-CRI 2020 Conference
This year’s 2020 AACI-CRI conference went virtual, but the research community still collaborated and shared best practices on how to keep moving clinical research forward.
12 Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete, compliant documentation during a trial can be challenging. ISFs help ensure ICH E6 (R2) section 8 are met by checking the content of a variety of documents.
Fireside Chat: The Future of Clinical Trials and Site Engagement
Fireside Chats, a new virtual series presented by Advarra, launches this month, bringing the research community together to discuss challenges and potential solutions.