Leading CRO Accelerates Startup with Integrated, Centralized IRB/IBC Reviews
Discover how Parexel accelerated mRNA study startups with Advarra’s integrated IRB and IBC reviews, achieving rapid timelines and budget goals.
Best Practices for IRB Review of DCTs: Expert Perspectives
A variety of distinctive ethical, regulatory, and legal challenges stand in the way of greater adoption of decentralized clinical trial (DCT) components and study designs.
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.
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.
Unlocking Study Activation: 2023 Study Activation Report
Discover how evolving tools and processes affect study activation and learn strategies to reduce delays and administrative burdens in research.
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.
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.
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.
General Perceptions of Clinical Trials in 2023
Significant growth and adoption of new research approaches in the life sciences industry has driven an increasingly complex and competitive
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
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.