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 your organization?
You would have daily access to IRB members with extensive experience and expertise in the therapeutic areas related to your study. You would experience the comfort of knowing the work was in full compliance with all relevant regulations and guidelines. You would trust the timeline, and receive timely reviews to avoid delays. And if you’re lucky, you would even have transparent communication. The best part? You’d have peace of mind.
An IRB experience like this might seem like a distant fantasy.
Many of our clients come to Sabai after experiencing incorrect regulatory interpretation, inefficient procedures and even blatant mistakes in study documents. Some have shared their experiences with ICF errors, cumbersome communication, and ultimately, delays and sponsor frustration.
When you’re uncertain whether your IRB partner is going to return key deliverables promptly, or when you can’t know for sure if they’ll be accurate, your ability to form a meaningful trial timeline is compromised. In such circumstances, you might even begin to feel like a low priority.
IRB review doesn’t have to be frustrating and confusing.
Settling for the “traditional” cookie-cutter IRB experience isn’t necessary. You can work with an experienced, reliable IRB partner and receive engaged, proactive attention from a responsive team of experts, clear timelines and unfailing accountability.
You can even experience peace of mind.
What Makes Sabai Different
At Sabai, we trust in the impact of engaged communication throughout a project, particularly its ability to mitigate revisions down the road. That’s why we take the time to truly familiarize ourselves with your team and the unique needs of your study.
Here’s what that looks like in action:
- Kick-off call identifying the total array of questions required to establish timeline expectations
- Initial study-level submission fact-finding via real-time conversation with Sabai team members, not a questionnaire
- Consistent accessibility with us as your expert IRB contact; reliable communication throughout our entire working relationship
- Transparent timelines and accountability for key deliverables
The result? Reassurance and peace of mind throughout the entire IRB review process.
Institutional Review Board (IRB) Services from Sabai
With Sabai’s superior IRB services, your organization is equipped with two premier institutional review boards adherent to U.S. DHHS and FDA Regulations, as well as the Belmont Report, ICH GCP and NIH Guidelines and local and state laws. Service offerings include:
- Multi and Single Sight/Investigator studies in pharma, device and human factors, biotech, social-behavioral, natural history, registry and investigator-initiated projects
- Single-patient expanded access and compassionate use
- Exempt Determination reviews
- Initial and continuing review of research and ongoing review (i.e. amendments and safety reporting)
- Determinations of relevant research requiring IRB review
- Informed consent form pre-reviews, consultation, and development
- Translation Services
- Generic Materials
Whether you’re in need of a streamlined IRB review process or institutional biosafety committee IBC services, our team of experts is one phone call away. From our customized consulting services to concierge IRB and IBC submission to biosafety training and management, Sabai brings you and your team peace of mind.
An accessible and reliable IRB partner means more than swift, efficient and accurate review.
It means Sabai.
