Clinical Biosafety Services
Provides Institutional Biosafety Committee (IBC) services including centralized IBC setup and administration, NIH Guidelines compliance support, IBC submission concierge and continuing review services, study-specific biosafety risk assessments, site biosafety verifications, and a library of guidance materials and external regulatory resources to support clinical research involving recombinant or synthetic nucleic acids.
Industries
Nr. of Employees
small (1-50)
Clinical Biosafety Services
Chesterfield, Missouri, United States, North America
Products
IBC Initial Study Cycle Guide
Guide describing the initial IBC review cycle and expected steps for study initiation.
Required Documents for IBC Review
Checklist of documents typically required for IBC meetings and reviews.
StartSMART Accelerated IBC Services
Overview of an accelerated IBC services offering to expedite IBC review timelines.
Pre-Meeting Site Verifications FAQ
FAQ and checklist resources for performing pre-meeting site verifications prior to IBC review.
Eyewash FAQ
Guidance concerning eyewash stations and related site requirements.
Incident Reporting Guidelines
Guidance for reporting biosafety incidents and managing incident documentation.
IBC Initial Study Cycle Guide
Guide describing the initial IBC review cycle and expected steps for study initiation.
Required Documents for IBC Review
Checklist of documents typically required for IBC meetings and reviews.
StartSMART Accelerated IBC Services
Overview of an accelerated IBC services offering to expedite IBC review timelines.
Pre-Meeting Site Verifications FAQ
FAQ and checklist resources for performing pre-meeting site verifications prior to IBC review.
Eyewash FAQ
Guidance concerning eyewash stations and related site requirements.
Incident Reporting Guidelines
Guidance for reporting biosafety incidents and managing incident documentation.
Services
Establish and administer Institutional Biosafety Committees and support NIH registration for institutions conducting recombinant or synthetic nucleic acid research.
White-glove service to prepare, complete, and submit IBC applications and associated documentation on behalf of study teams to expedite approvals.
Ongoing support for annual and periodic IBC reviews, including updated risk assessments with study amendments to maintain continuous approval.
Pre-meeting checks and verifications of biosafety infrastructure and readiness prior to IBC review.
Provision of downloadable guidance documents and curated links to external regulatory resources to support biosafety compliance.
Establish and administer Institutional Biosafety Committees and support NIH registration for institutions conducting recombinant or synthetic nucleic acid research.
White-glove service to prepare, complete, and submit IBC applications and associated documentation on behalf of study teams to expedite approvals.
Ongoing support for annual and periodic IBC reviews, including updated risk assessments with study amendments to maintain continuous approval.
Pre-meeting checks and verifications of biosafety infrastructure and readiness prior to IBC review.
Provision of downloadable guidance documents and curated links to external regulatory resources to support biosafety compliance.
Expertise Areas
- Institutional Biosafety Committee management
- IBC submissions and NIH Guidelines compliance
- Clinical study start-up support and review coordination
- Biosafety risk assessment and document preparation
Key Technologies
- Biosafety risk assessment
- IBC/IRB concurrent review workflows
- Regulatory pathway navigation (NIH/CDC/OSHA/EPA)
- Site verification and facility assessment methods