We understand that navigating the NIH Guidelines, implementing an effective Institutional Biosafety Committee (IBC), or completing the IBC application processes can be burdensome. Shield Consulting provides the following services to ensure that your IBC functions optimally or that your clinical trial is efficiently reviewed by the IBC at your trial site(s):
We have extensive experience in registering and managing hundreds of effective IBC’s. Whether you just received federal funding requiring establishment of an IBC, or if you wish to have an established IBC assessed to ensure optimal performance, we can provide the necessary support so your biological research can be conducted safely and compliantly.
Shield Consulting 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, Shield provides each IBC submission with a customized supplemental risk assessment document that has been tailored to each study by our industry leading professionals.
Our subject matter experts specialize in human gene therapy clinical trials utilizing:
Contact us to learn more, today, on how Shield Concierge can accelerate & streamline your gene and cell therapy study start-up.