Quality & Compliance
Built on Trust and Regulatory Excellence
Our Commitment to Quality
At BioPartners, quality is not a single step in a study—it is the foundation of everything we do.
We operate under a unified Quality Management System (QMS) designed to ensure scientific integrity, regulatory compliance, patient safety, and operational consistency across all studies and clinical workflows.
Our integrated CRO + clinical site model gives us complete oversight of every procedure, team member, and data point. This allows us to deliver accurate, reproducible, and audit-ready results—every time.
Regulatory Framework
BioPartners adheres to the highest global regulatory standards, including:
- ICH-GCP (International Council for Harmonisation – Good Clinical Practice)
- FDA regulations (21 CFR Part 50, 56, 312, 812)
- HIPAA privacy and security requirements
- GDPR and international data protection laws
- IATA regulations for biospecimen transport
- ISO-aligned quality and information security frameworks
Our procedures are continuously updated to reflect evolving regulatory expectations, industry best practices, and sponsor-specific requirements.
Quality Management System (QMS)
Our QMS provides complete oversight from study initiation to final reporting. It includes:
Our therapeutic capabilities continue to expand as we grow our global network and strengthen partnerships with leading pharmaceutical, diagnostic, and biotech companies. With broad experience across multiple disease areas and access to diverse patient populations, BioPartners is positioned to support studies of varying complexity and scale.
Comprehensive SOP Framework
Standardized procedures govern all CRO and clinical site operations, including patient screening, enrollment, biospecimen collection, laboratory processing, storage, shipping, data entry, documentation, and quality verification.
Document Control & Version Management
All documents follow strict version control to ensure accuracy, traceability, and compliance throughout the study lifecycle.
Internal Audits & CAPA
Regular internal audits monitor operational alignment, while Corrective and Preventive Action (CAPA) processes drive continuous improvement and risk reduction.
Staff Training & Competency Assessments
All personnel complete:
- GCP training
- Role-specific technical training
- Study-specific training
- Ongoing competency evaluations
- Annual recertification
Every team member is qualified to deliver consistent, compliant, high-quality results.
Data Integrity & Security
Data integrity is essential for scientific credibility and regulatory acceptance.
Our systems and workflows include:
- Encrypted data storage and secure data transfer
- Role-based access controls
- Full audit trails for all data transactions
- Pseudonymization and de-identification of patient data
- Compliance with HIPAA, GDPR, and international data protection standards
We ensure that every dataset is accurate, complete, traceable, and inspection-ready.
Biospecimen Quality & Chain-of-Custody
High-quality biospecimens require strict control at every step.
BioPartners maintains:
- Validated and study-specific collection and processing protocols
- Temperature-controlled storage (2–8°C, –20°C, –80°C)
- Calibrated equipment with documented maintenance records
- IATA-compliant packaging and shipping
- Electronic chain-of-custody tracking
- Detailed manifests and comprehensive metadata
Our biospecimen workflows have supported thousands of diagnostic performance studies, biomarker programs, and therapeutic research initiatives worldwide.
Site Operations & Participant Safety
As an Independent Clinical Research Site, we operate under the highest ethical and clinical standards, including:
- IRB-approved protocols
- Informed consent compliance
- Safety monitoring procedures
- AE/SAE documentation and reporting
- Oversight by qualified investigators and clinical staff
Patient well-being, dignity, and confidentiality remain central to our mission.
Real-Time Oversight &
Risk Mitigation
Our integrated operational model enables proactive, continuous oversight:
- Real-time communication between site, CRO teams, and sponsors
- Rapid escalation pathways for deviations or unplanned events
- Ongoing risk assessments and mitigation strategies
- Daily quality checks for data, biospecimens, and documentation
This ensures that potential issues are identified early—before they affect timelines, compliance, or data quality.
Audit-Ready at All Times
BioPartners maintains full audit readiness for:
- Internal quality audits
- Sponsor audits
- Regulatory inspections
Our readiness includes:
- Organized regulatory binders
- Complete and up-to-date documentation
- Current SOP libraries
- Training and competency records
- Deviation/CAPA documentation
- End-to-end process traceability
Our commitment to compliance gives sponsors confidence at every stage of their project.
Quality Isn’t a Goal — It’s Our Culture
Quality defines BioPartners.
It shapes how we train our teams, design our systems, manage facilities, and execute every study.
We believe operational excellence is the foundation of scientific excellence—and we uphold this standard for every sponsor, partner, and patient we serve.
