The Shield Consulting division of Sabai Global, in partnership with Clinical Biosafety Services (CBS) and Castle IRB, provides expert assistance on issues of biosafety, biorisk management and biosecurity. Our highly trained and experienced consultants bring a wealth of knowledge in delivering hands-on training, program development, and interim staffing of biosafety programs. Our approach is based on developing a client partnership towards meeting end goals in a cost-effective and sustainable manner for gene therapy sponsors, biopharma, CROs, institutions, and clinics.

Shield Consulting provides assistance in the areas of:

  • Program Assessment
  • Biosafety Program Staffing
  • Clinical Biosafety and Human Gene Transfer Support
  • Biosafety for Large Scale Manufacturing
  • Gene Therapy and Biosafety Regulatory Guidance
  • Policy and Program Development
  • Standard Operating Procedures and Biosafety Manuals
  • Biocontainment Laboratories
  • Biosecurity
  • Disaster Preparedness and Emergency Response
  • Workshops and Training

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Mission Statement

Our mission and expertise at Clinical Biosafety Services is to provide accelerated, compliant review of gene transfer/gene therapy clinical trials to a convened review of a site-specific Institutional Biosafety Committee (IBC). We do this by understanding the challenges in the two client relationship of serving an institution and a sponsor.

Our focus is to accelerate the trial, and remove regulatory burden and uncertainty by having our highly trained experts provide friendly, knowledgeable support during the review process. We understand these therapeutics will change medicine, and our service is to bring the trial to enrollment fruition, quickly and compliantly.