Sponsors: Are Your Sites Ready for an FDA Inspection?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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mRNA Cancer Vaccines and Therapies: An Overview
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While
Trend Report: DE&I in Clinical Research: Where we are Today
Explore the state of DE&I in clinical research with survey insights on diversity plans, budgeting efforts, and progress in trial representation.
Unpacking The Role of a Right-Sized QMS in Study Startup
The study startup process involves a multitude of tasks and activities multiple teams coordinate to ensure the successful study initiation.
GxP Compliance in Clinical Research
Explore GxP principles in clinical research, from ensuring safety and integrity to regulatory adherence, with real-world case study insights.
A Phased Approach to QMS
A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study.
Global, Comprehensive Audit Support Case Study
A top 20 pharma organization partnered with Advarra Consulting to streamline a centralized audit function and establish an ongoing regulatory framework to fulfill stringent regulatory requirements. This Case Study is an overview of their findings.
Clinical Trial Startup: Insights from the Industry
The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology,
QMS for Artificial Intelligence
This case study covers a biotech company that partnered with Advarra, seeking to create a risk-based and proactive quality management system (QMS) to strengthen their service offering.
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,
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.