Good Manufacturing Practices: When Do They Apply?
Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.
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Impact of sIRB Mandates on Study Teams
As sIRB mandates reshape the clinical trial landscape, study teams must navigate unique challenges while ensuring compliance and participant protection.
Key Items Auditors Look for When Reviewing an Investigator Site File
Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.
Interim Staffing: Reinvigorating Your Human Research Protections Program
Interim staffing offers HRPPs specialized expertise, fresh perspectives, and support for accreditation and structural improvements without disrupting daily operations.
Striking the Balance: Ethics, Inclusion, and Vulnerability in Research
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
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.
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.