All BioPartners studies undergo review and approval by an Independent Review Board (IRB) before initiation.

IRB oversight ensures:

• Ethical conduct of research
• Protection of participant rights and welfare
• Accuracy and transparency of the Informed Consent Form (ICF)
• Compliance with federal regulations and ethical guidelines

We collaborate with well-established central IRBs, enabling fast turnaround times and rapid activation.

Ongoing responsibilities include:

• Continuing reviews
• Reporting of AEs, SAEs, and protocol deviations
• Amendment submissions

Continuous ethical oversight throughout the study

BioPartners uses rigorous de-identification procedures that comply with HIPAA, GDPR, and FDA guidance.

Our privacy protections include:

• Coded participant IDs instead of names
• Secure, encrypted data systems
• Access restricted to authorized team members
• Separate storage of identifiable data
• Removal of all personal identifiers before sharing with sponsors
• De-identified biospecimen labeling with no personal information

All datasets provided to sponsors are fully de-identified, secure, and regulatory compliant, ensuring participant privacy while supporting high-quality analysis.

We follow validated, standardized procedures for:

• Sample collection
• Centrifugation, aliquoting, stabilization
• Storage at 2–8°C, –20°C, –80°C
• Chain-of-custody and tracking
• IATA-certified shipping

All samples include detailed metadata and processing records.

Yes.

We can operate as:

• A lead site in U.S.-based multi-site studies
• A U.S. site within global studies
• A CRO overseeing multiple U.S. and international sites

We also offer robust site coordination and oversight.