article Articles

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.

Making a Case for HRPP Interim Staffing

Providing interim HRPP support can help your team fill in staffing gaps while staying on top of research and moving protocols forward.

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.

Good Manufacturing Practices: When Do They Apply?

Oftentimes, research teams struggle with knowing when to apply current Good Manufacturing Practice regulations. The FDA outlines expectations for the application of cGMP to investigational drugs.

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.

Fitting Your Needs: Pandemic-Proofing Protocols

The COVID-19 pandemic forced an era of research quickly adjusting to continue high-quality research. Most adaptions, however, have positioned research to be more patient centric, streamlined, and remote.

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.

Social Media’s Role in Clinical Research

Social media connects users worldwide, helping people stay connected. Its role in clinical research has many recruiting and retention benefits.

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