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.
IRB
SAE Reporting and the IRB: Adverse Events in Drug Studies
Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible
sIRB Review for Multicenter Research: A Guide for Institutions
Prepare for single IRB review with insights on reliance agreements, communication plans, lead site responsibilities, and technology needs.
IRB Review of Changes to Previously Approved Research
During the course of study conduct, most research involving human participants will require some form of planned modification or revision.
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.
What Happens When a Study Fails to Meet Its Recruitment Targets?
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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.
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.
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,
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,