Research

Biospecimen Management Best Practices

Evaluate compliance with NCI Best Practices and ISBER guidelines for biospecimen collection, processing, storage, and distribution in research …

BMBL Biosafety Assessment

Evaluate compliance with CDC/NIH Biosafety in Microbiological and Biomedical Laboratories guidelines for safe handling of infectious agents

CA CMIA Medical Privacy Compliance

Evaluate compliance with California Confidentiality of Medical Information Act (Civil Code §56-56.37), covering patient authorization, disclosure …

CCPA/CPRA Compliance Assessment

Evaluate compliance with California Consumer Privacy Act and California Privacy Rights Act requirements for businesses handling California resident …

CLIA Compliance Assessment

Evaluate compliance with Clinical Laboratory Improvement Amendments for laboratory quality and patient safety

Assessment for Medicare Coverage Analysis and billing compliance for clinical trial services separating research costs from standard care

Assessment for research conflicts of interest management, financial disclosure requirements, and institutional COI policies per PHS and NSF …

Assessment for records management, data retention policies, and secure destruction procedures for regulated industries

EPA Hazardous Waste Management (RCRA)

Evaluate Resource Conservation and Recovery Act (RCRA) compliance for research and biotech labs generating hazardous waste, covering waste …

EPA RCRA Hazardous Waste Compliance

Evaluate Resource Conservation and Recovery Act compliance for hazardous waste generation, storage, treatment, and disposal in laboratory and …

EU IVDR 2017/746 - IVD Compliance Assessment

Evaluate compliance with European In Vitro Diagnostic Regulation 2017/746 for diagnostic tests, companion diagnostics, and laboratory-developed tests …

Assessment for EAR/ITAR compliance, deemed export controls, and research security for organizations with foreign national access or international …

FedRAMP Authorization Readiness Assessment

Evaluate readiness for FedRAMP authorization to provide cloud services to federal agencies, based on NIST 800-53 security controls

GDPR Compliance Assessment

Evaluate compliance with EU General Data Protection Regulation requirements for processing personal data of EU residents

Good Clinical Practice (GCP) Compliance Assessment

Evaluate compliance with international ethical and quality standards for clinical trial design, conduct, and reporting

Healthcare Accessibility (ADA & Section 504)

Evaluate healthcare accessibility compliance covering physical access, effective communication, program access, and auxiliary aids/services per ADA …

Healthcare Emergency Preparedness (CMS Rule)

Evaluate CMS Emergency Preparedness Rule compliance covering emergency plans, policies, communication, training, testing, and integrated healthcare …

HHS 405(d) Cybersecurity Assessment

Evaluate alignment with Health and Human Services voluntary cybersecurity practices for the healthcare industry

HITECH Act Compliance Assessment

Evaluate your compliance with the Health Information Technology for Economic and Clinical Health Act

Assessment for Institutional Animal Care and Use Committee compliance, USDA Animal Welfare Act, and PHS Policy for vertebrate animal research

ICH-GCP Clinical Trial Management

Evaluate compliance with ICH E6(R2) Good Clinical Practice guidelines for clinical trial design, conduct, monitoring, and documentation

IRB & Human Subjects Research Compliance

Evaluate compliance with 45 CFR Part 46 (Common Rule) requirements for Institutional Review Boards and human subjects research protection

ISO 14001 Environmental Management System

Evaluate ISO 14001:2015 environmental management system compliance, covering environmental policy, planning, implementation, monitoring, and continual …

ISO 27001:2022 ISMS Assessment

Evaluate alignment with ISO/IEC 27001:2022 requirements for establishing, implementing, maintaining, and continually improving an Information Security …

Lab & Facility Building Code Compliance

Evaluate building and fire code compliance for laboratory, cleanroom, and BSL facilities covering construction, life safety, egress, and specialized …

NIH Recombinant DNA Guidelines Assessment

Evaluate compliance with NIH Guidelines for research involving recombinant or synthetic nucleic acid molecules

NIST 800-53 Rev 5 Assessment

Evaluate compliance with NIST SP 800-53 Revision 5 security and privacy controls for federal information systems and organizations

OSHA Lab Standard Compliance (29 CFR 1910.1450)

Evaluate Occupational Safety and Health Administration (OSHA) laboratory standard compliance for research and clinical labs working with hazardous …

OSHA Workplace Safety Compliance

Evaluate OSHA general industry workplace safety compliance covering hazard communication, recordkeeping, emergency action plans, and worker protection

Outbreak Investigation & Infection Control

Evaluate outbreak investigation and infection control readiness covering contact tracing, infection prevention, public health coordination, and …

Pandemic Response & Infectious Disease Preparedness

Evaluate pandemic preparedness covering surge capacity, infection control, PPE stockpiling, crisis standards of care, and workforce protection

Assessment for state pharmacy board licensure and DEA controlled substance registration for pharmacies and research facilities

Public Health Reporting & Surveillance

Evaluate public health reporting compliance covering disease surveillance, immunization registries, syndromic surveillance, and vital statistics …

Research Data Management & FAIR Principles

Evaluate research data management practices including FAIR principles (Findable, Accessible, Interoperable, Reusable), data integrity, and regulatory …

SOC 2 Type II Readiness Assessment

Evaluate readiness for SOC 2 Type II audit based on AICPA Trust Services Criteria for security, availability, processing integrity, confidentiality, …