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):

IBC Support:

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.

Concierge Services:

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:

  • Recombinant and synthetic vaccines
  • Chimeric Antigen Receptor T Cell Therapy (CAR-T)
  • Gammaretro- and lentiviral vectors
  • Adeno and adeno-associated viral vectors
  • Liposomal delivered RNA & DNA investigational agents
  • CRISPR technologies

Contact us to learn more, today, on how Shield Concierge can accelerate & streamline your gene and cell therapy study start-up.

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Mission Statement

Shield Consulting's Mission is to provide innovative products and services that promote new and sound solutions in helping our customers find better ways to do important work. We are dedicated to offering the highest quality of Customer Service, delivered with a sense of warmth and respect. We are committed to being a true partner by always keeping our customers' best interests at heart. Our highly skilled experts are passionate about working hard to support our Customers' needs so that they can continue to serve the highest level of service for others.