HRPP staffing is essential for maintaining research ethics, even with sIRB mandates streamlining review processes for multisite studies. Discover key HRPP roles and benefits.
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 guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.
Human research protection programs (HRPPs) play a critical role in protecting the rights, safety, and welfare of research participants. A
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
As research institutions are designing studies and recruiting participants for them, they must maintain compliance and ensure their study is
The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
An inspection readiness program can assess compliance, address deficiencies, and prepare sponsors and CROs for potential FDA inspections.
The Centers for Medicare & Medicaid Services (CMS) released a letter outlining routine costs in clinical trials for patients eligible
Adhering to FDA guidelines is crucial for sponsors and sites to ensure successful inspections, enabling product approvals and faster market access.
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
