Clinical Trial Participant Rights and the Importance of Ethical IRB Review
Author: Oleg Kisselev, IRB Chair As the number and complexity of clinical trials continue to grow, so does the imperative to ensure that participants are…
Tailor-Built and Thoroughly Trained: Emergency Preparedness using the BioWOPER Methodology from Sabai
Introduction As routine handlers of highly dangerous biological materials and processes, laboratories throughout the biopharmaceutical manufacturing industry are required to possess strict emergency response protocols…
Experience the Sabai Difference: Swift, Proactive, Reliable IRB Review
Let’s imagine for a moment: picture your ideal Institutional Review Board (IRB) experience. What would it be like? How would it impact your team and…
Expect More From Your IRB: Quality and Accountability in the Sabai Experience
Introduction: The No-Choice Illusion You’ve seen it, and we know it: The pharma industry’s two-organization monopoly of IRB services promises devotion to your clinical trials…
Biosafety Emergency Response Built for Your Processes and People: Sabai’s BioWOPER™
Overview In stressful situations, it’s human nature to react instinctively rather than respond logically—to run towards or away from a developing emergency. Yet, laboratories throughout…
The Sabai Difference: Engaged, Empowering and Efficient Institutional Biosafety Committee (IBC) Review
From the CRO perspective, navigating the IBC process for the first time can feel daunting. And even experienced personnel will sometimes shudder at past IBC…
Concerns of the Rare Disease Patient Community: 7 Critical Instances Where FDA Guidance Responds (or Doesn’t)
Sabai IRB Chair Stephanie Solomon Cargill attended a series of FDA engagement sessions, gathering valuable insights on how the latest guidance accords with the concerns, interests…
