Sabai IBC Services
The Sabai Institutional Biosafety Committee (IBC) team leads the way with the most certified biosafety professionals within an organization.
IBC Review
Sabai IBC Services can provide a centralized IBC solution ~ or work with an Institution to create an additional HGT-specific IBC for their facilities.
- Flexible and comprehensive support for IBC setup, NIH registration and administration
- Personalized education on IBCs and NIH requirements for new sites
- Resources and support for an existing IBC through staffing, a second HGT-specific IBC, or other institution specific needs
- Coordination of concurrent reviews to deliver efficient, time-saving IBC and Institutional Review Board (IRB) reviews for all participating research sites throughout our services
- Global support for IBC services as research with the NIH Guidelines goes beyond US borders
Why Do I Need An IBC?
Review of a clinical trial by an Institutional Biosafety Committee is required by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules when:
- 1. The investigational product contains recombinant or synthetic nucleic acids that meet certain criteria under Section III-C of the NIH Guidelines, AND
- 2. This research is conducted at an institution that receives support for recombinant/synthetic nucleic acid research from NIH, or
- 3. This research is sponsored by an institution that receives support for recombinant/synthetic nucleic acid research from NIH, or
- 4. The investigational product was developed with NIH funds if the Institution that developed the IP sponsors or participates in the trial.
5. Still unsure? No problem, contact us today to speak with an expert.
IBC Concierge Services
We understand that navigating the NIH Guidelines while completing Institutional Biosafety Committee (IBC) application processes can be burdensome. Sabai’s IBC Concierge Services accelerates study startup operations by streamlining submission to and approval by local IBCs.
Concierge Services
Sabai Concierge Services provides a white-glove experience to study teams, contract research organizations (CROs), and Sponsors to alleviate the difficulties associated with IBC regulatory requirements. Our team of experts deliver a seamless facilitation of the IBC application processes by working alongside your stakeholders to expedite completion and submission of all required documentation.
In addition to our white-glove IBC submission services, Sabai provides each IBC submission with a customized supplemental risk assessment document that has been tailored to each study by our industry leading professionals.
Concierge Plus [+]
Concierge Plus provides Sites with continuing review support to ensure ongoing approval throughout the entire duration of the clinical trial. This includes assistance with annual/periodic IBC review processes per an Institution’s IBC Charter. Additionally, Sabai will provide the study team with updated Risk Assessments coinciding with amendments to all Sponsor Study documentation (e.g., Clinical Protocol, Investigator’s Brochure, Pharmacy Manual).
01
Sabai will coordinate with any combination of the Sponsor, CRO, and/or Site to identify the institutional stakeholders responsible for IBC submission.
02
Experts at Sabai harmonize with key personnel to substantially expedite the completion of all IBC associated regulatory requirements for successful submission to the IBC.
03
Our team will maintain communication with all stakeholders throughout the submission and review processes, including response to, and resolution of any required pre- and post-review actions to ensure full IBC approval.
04
Sabai Project Managers provide continuing IBC review support to the site study team to ensure current IBC approval throughout the duration on the clinical trial.
Sabai IBC Services has developed several frequently requested guidance documents to assist our clinicians and researchers. The following items are available for download below.
FAQ
Guidance
