Our Quality Management System (QMS) aligns with:

• ICH-GCP
• FDA regulations
• HIPAA & GDPR
• ISO-aligned quality and security standards
• IRB-approved protocols

We maintain:

• Controlled SOPs
• Training and competency documentation
• Internal audits
• CAPA processes
• Complete traceability

We are audit-ready at all times.

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

Due to our integrated model and established processes, we provide:

• Rapid feasibility assessments
• Fast IRB submission and approval
• Immediate site activation upon approval
• Accelerated patient recruitment

Sponsors typically experience significantly shorter start-up timelines with us.