Supporting services
At BioPartners, our supporting services strengthen every aspect of the clinical research lifecycle. These offerings enhance operational efficiency, improve study quality, and ensure that sponsors receive accurate, reliable, and regulatory-ready data.
Diagnostic & IVD Performance Studies
BioPartners specializes in diagnostic and IVD study execution, offering comprehensive support for:
- Sensitivity and specificity evaluations
- Comparator and method correlation testing
- CLIA-waived and point-of-care device studies
- Usability and human factors assessments
- Symptomatic and asymptomatic population enrollment
- Custom sample collection for analytical and clinical validation
Our controlled workflows, integrated CRO + site model, and scientific oversight ensure fast activation, consistent execution, and datasets suitable for FDA, CE, and global regulatory submissions.
Clinical Operations & Site Management
Our operations team supports the full study lifecycle, including:
- Study start-up and regulatory activation
- Recruitment strategy and enrollment planning
- Real-time patient flow coordination
- Monitoring visit support
- Delegation of authority oversight
- TMF management and documentation control
With our operational discipline, sponsors benefit from smooth execution, rapid issue resolution, and consistent performance across all study activities.
Regulatory Affairs
Our regulatory specialists maintain complete alignment with U.S. and international standards. We oversee:
- IRB/EC submissions, amendments, and continuing reviews
- Informed Consent Form (ICF) creation and updates
- AE/SAE/UADE safety reporting
- FDA, ICH-GCP, HIPAA, and GDPR compliance
- Inspection readiness, deviation documentation, and audit support
From initiation to closeout, we ensure that studies remain fully compliant and audit-ready.
Patient Recruitment & Retention
BioPartners provides targeted recruitment strategies supported by our clinical site and extended network. We deliver:
- Access to diverse demographic groups
- Hard-to-reach and rare disease populations
- Healthy volunteer cohorts
- Ethical outreach and engagement strategies
Our patient-centered approach promotes strong enrollment rates and exceptional retention.
Biospecimen Processing & Logistics
Our laboratory and logistics teams maintain strict quality control across all biospecimen workflows, including:
- Validated processing procedures (centrifugation, aliquoting, stabilization)
- Temperature-controlled storage (2–8°C, –20°C, –80°C)
- Chain-of-custody tracking
- IATA-certified global cold-chain shipping
These processes ensure biospecimen integrity for downstream analytical, diagnostic, and biomarker studies.
Ready to Begin?
BioPartners delivers high-quality, audit-ready clinical research with unmatched speed, precision, and compliance.
