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CLINICAL SAMPLE SOURCING
Prospective
Biospecimen Collections
Built for IVD Evidence
Prospective Collections
for IVD Evidence
We design and operationalize IRB/IEC-approved prospective collections mapped to your claims and evidence plan.
Study Types Supported
.01
Research and proof of concept
.02
Analytical validation
.03
Clinical performance
.04
Positivity enrichment
.05
Rare matrices
.06
CLIA-Waiver flex
.07
Reproducibility
.08
Bridging and lot release
Designed for
IVD Programs
Our prospective collections service provides a traceable chain of custody and is engineered for IVD programs.
Matched specimens, matrices, or panels aligned to protocol and intended use.
Positivity enrichment or targeted recruitment for low prevalence conditions.
Flex studies of truly naïve operators, captured under controlled methods.
Representative
Programs
.01
Research
Assay proof of concept studies, clinical validity of biomarker studies.
.02
Analytical Validation
Sensitivity, LoD, specificity, precision, reference interval, stability.
.03
CLIA-Waiver Flex Studies
Intended use environments, naïve operators, operator variability capture.
.04
Clinical Performance
Real-world positivity‑enriched cohorts, targeted recruitment, reference standard/comparator benchmarks, and study design.
.05
All Matrices and Special Handling
Saliva, capillary blood, nasal swabs, stool, urine, plasma/serum, others.
How It Works
We provide end-to-end operational ownership with clear handoffs, SLAs, and audit-ready documentation:
Expertise
01
CORE team – Industry builders/leaders.
Speed
02
Qualified network + proven workflows; Rapid accrual – delivery.
Compliance
03
Quality, Clinical & Regulatory compliance from day one.
Service
04
Dedicated team for personalized client support.
Quality & Compliance
We operate under a CRO grade quality system aligned to ICH GCP, with privacy and data protection controls appropriate to each program.
.01
ICH-GCP
.02
Audit Trails & Access Control
.03
Chain of Custody
.04
PHI & Privacy (HIPAA/GDPR)
.05
Document Control & Training Records
.06
Temperature Monitoring & Alarms
Cohorts & Metrics
Targeted recruitment and pre‑screening strategies for low‑prevalence cohorts, aligned to protocol needs.
Healthy, symptomatic, and adjudicated cohorts available; multi‑region site networks as required.
Full material traceability and storage conditions documented; customizable panel assembly.
Targeted recruitment for indications including cancer, neurological, cardiac, diabetes, and infectious disease.
Key attributes that are targeted include Ethnic Diversity, Treatment Naïve, and Longitudinal Collections.
Experts on your side
Need support driving your IVD forward? Reach out to DCN Dx Experts for solutions.
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