In-Vitro Diagnostics
Support Comprehensive site management for diagnostic test development, including CLIA-certified facilities, regulatory pathway guidance, and specialized protocol development for IVD submissions
Biospecimen Research Operations
End-to-end management of specimen collection studies with trained clinical teams, validated SOPs for sample integrity, and multi-specialty site networks providing diverse patient populations.
Remnant Retention Programs
Strategic utilization of existing clinical specimens through precise verification processes, streamlined procurement workflows, and regulatory compliance oversight.
Precise verification of remnant vs. prospective collections
Maximizing efficiency at collection sites to facilitate rapid sample accrual
Cost-analysis of projected goals
Transparent timeline benchmarks
Client Benefits
Staff training to efficiently adapt new clinical projects into existing workflows
Guidance interpreting research protocols
Management of benchmark success
Increased lab revenue
Expert operational cost-analysis
Career development opportunities
Site Benefits
Integrated Clinical Research Management
Automated Operations
Monthly site payment processing, invoice generation, regulatory submission tracking, and performance analytics dashboard.
eSource Integration
Streamlined data capture that eliminates duplicate entry, integrates participant stipends, and generates CRF-equivalent reports for regulatory submissions.
Observational Studies
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Real-world evidence generation
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Post-market surveillance studies
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Registry development and maintenance
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Long-term follow-up studies
eCTMS (Electronic Clinical Trial Management System)
Purpose-built for non-interventional studies with essential document repository, automated milestone tracking, and real-time study oversight capabilities including data monitoring and queries.
Biospecimen Research
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Prospective sample collection protocols
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Multi-site biomarker studies
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Tissue and fluid specimen collection
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Quality assurance and chain of custody management
In-Vitro Diagnostics
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Point-of-care testing validation
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Companion diagnostic development
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Laboratory-developed test studies
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Human factors and usability studies
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Simulated home environment testing for OTC diagnostics
Core Services
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