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
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Discover how biotech organizations navigate the unique challenges of cell and gene therapies, from regulatory shifts to recruitment and market uncertainty.
Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and
IVDs diagnose and monitor health using biospecimens, often in labs. FDA-regulated but varied in compliance, IVDs require careful IRB review preparation.
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
