GxP Best Practices for Safer, Smarter, Faster Clinical Research
GxP guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.
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Beginner’s Guide to Human Research Protection Programs
Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and welfare of research participants. A
sIRB 101: An Introduction to Relying on an External IRB
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Optimizing Your Human Research Protection Program: The Role of Quality Training
As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is
Public Perceptions of Clinical Trials: A Comprehensive Survey
The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight
Inspection Readiness: Before, During, After
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Don’t Get Caught Off Guard: Inspection Readiness for Sponsors and CROs
An inspection readiness program can assess compliance, address deficiencies, and prepare sponsors and CROs for potential FDA inspections.
New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy
The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible
Ace Your Next FDA Inspection
Adhering to FDA guidelines is crucial for sponsors and sites to ensure successful inspections, enabling product approvals and faster market access.
Biotech Organization Partners with Advarra to Become Inspection Ready
An established biotech organization sought out a partner to provide investigator site audits, trial master file (TMF) audits, for-cause audits, and other quality assurance services. Turning to Advarra, they developed a partnership through Advarra’s proven GxP services and successful U.S. Food and Drug Administration (FDA) guidance. Download the case study to learn more
4 Unique Challenges of Oncology Trials
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
FDA/OHRP Harmonization and Your HRPP Operations
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.