FAQ

We support:

• Phase II–IV clinical trials
• IVD and diagnostic performance studies
• Device usability and human factors research
• Prospective biospecimen collection studies
• Observational and registry-based research
• Retrospective biospecimen retrieval
• Longitudinal and multi-timepoint sampling

Our integrated CRO + clinical site model allows for rapid, consistent, and high-quality study execution.

We have experience across more than six major therapeutic areas, including oncology, infectious diseases, respiratory conditions, endocrine and metabolic disorders, cardiovascular disease, women’s health, urology, and rare diseases.

We are able to expand into new therapeutic areas as required by the study.

Yes.

BioPartners provides complete end-to-end study management, including:

• Protocol development
• Feasibility & patient population assessments
• IRB submissions
• Monitoring & quality oversight
• Data and documentation management
• Study reporting and closeout

Sponsors may choose full-service support or individual services as needed.

Yes — this is one of our core strengths.

We operate as a global full-service CRO and an independent, actively enrolling clinical research site.

This dual structure reduces hand-offs, accelerates start-up, and ensures consistent oversight and documentation.

We have extensive experience with:

• Sensitivity & specificity evaluations
• Comparator and method correlation studies
• Multi-swab and multi-matrix testing
• CLIA-waived and point-of-care device assessments
• Self-collection and usability studies
• Enrollment of symptomatic & asymptomatic populations

Our workflows generate regulatory-ready datasets for FDA, CE, and global submissions.

We operate in:

• United States — independent research site (California)
• Eastern Europe — strong partner site network

This allows global access to diverse patient populations and rapid recruitment.

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.

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

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.

We recruit:

• Healthy volunteers
• acutely or chronically ill adults
• Pregnant or postpartum individuals (if applicable)
• Diverse demographic and socioeconomic populations
• Disease-specific cohorts
• Rare and hard-to-recruit indications

Recruitment is tailored to each protocol.

Yes.

Feasibility responses are typically delivered within days and include:

• Recruitment projections
• Inclusion/exclusion considerations
• Operational and logistical requirements
• Site capabilities
• Timeline expectations

We provide a full suite of regulatory and site documentation, including:

• IRB approvals
• ICF versions
• Investigator CVs, licenses, training certificates
• Delegation logs
• SOP summaries
• Regulatory binder contents
• Laboratory certifications (as applicable)
• CLIA-related documentation
• Site qualification materials

Pricing is based on:

• Study procedures and complexity
• Sample or visit volume
• Processing and logistics requirements
• Recruitment expectations
• Study duration

We provide transparent quotes and support iterative revisions.

Simply submit your request.

Our team will respond promptly with next steps, feasibility timelines, and required documentation.