Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry,
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Enhancing Research Ethics: Understanding HRPP Staffing and the sIRB Mandate
HRPP staffing is essential for maintaining research ethics, even with sIRB mandates streamlining review processes for multisite studies. Discover key HRPP roles and benefits.
Advarra Implements Global Clinical Quality Assessment and Corrective Action Initiatives Case Study
A mid-size clinical research and development (R&D) device company conducted studies in complex therapeutic areas without a clinical trial infrastructure in place to maintain required good clinical practices (GCP). Learn more about what Advarra put in place to help this organization improve its global GCPs, compliant clinical trial infrastructure, and quality framework in this case study.
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.
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.