Clinical 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

CLIA Compliance Assessment

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

Good Clinical Practice (GCP) Compliance Assessment

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

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

NIH Recombinant DNA Guidelines Assessment

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

Research Data Management & FAIR Principles

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