In-Vitro Diagnostics
INCREASE provides clinical performance studies, site and laboratory qualification, and regulatory dossier preparation for in-vitro diagnostic developers, backed by our in-house laboratory testing capabilities.
Aligned with
Key Capabilities
Diagnostic performance evidence supported by our in-house central laboratory and qualified site network.
Study Design
Analytical and clinical performance study design.
Site & Lab Qualification
Qualification of sites and laboratories.
Dossier Preparation
EU IVDR and AMDD dossier support.
Sample Management
Specimen logistics, biobanking, and chain of custody.
Reference Testing
Comparator and reference method testing.
Regulatory Affairs
IVD registration and submission management.
Clinical Performance Studies
Prospective and retrospective clinical performance evaluation.
Biostatistics & Analysis
Statistical analysis plans, sensitivity, specificity, ROC analysis.
Post-Market Surveillance
PMPF plans, vigilance reporting, and complaint management.
Integrated Laboratory
Lab & Diagnostic Services
Backed by our in-house central laboratory — samples processed on site for faster turnaround and unified data.
Clinical Pathology
Clinical Microbiology
Antibody-based Assay
Genomics & Molecular
Ready to discuss your IVD program?
Our integrated team is ready to design a study tailored to your development goals.