Analytical and clinical performance evaluation for IVDs — design, execution, and submission-ready PER compilation.
Why teams choose us
Analytical + clinical + dossier — under one accountable team.
Sensitivity, specificity, LoD, LoQ, linearity, interference, precision studies.
Real-world sample testing against gold-standard comparators across NABL sites.
WHO, NIBSC, and proprietary reference materials sourced and characterized.
NABL labs, hospital partners, IRB submissions, contract negotiation.
Pre-specified analysis plan, ROC curves, confidence intervals, k-statistics.
Dossier-ready PER with full traceability to raw data and study logs.
Six fixed milestones with clear deliverables at each stage.
Intended use, target population, comparator, and sample size locked in writing.
Analytical + clinical protocols, statistical analysis plan, sample matrices.
NABL site contracts, IRB submissions, reference panel acquisition.
Patient enrollment, sample testing, comparator runs, quality controls.
Statistical analysis, sensitivity/specificity calculation, interference confirmation.
Performance Evaluation Report, supporting documentation, dossier integration.
PER specialists — not generalists adapting medical device skills.
“The performance evaluation report held up under reviewer scrutiny, with every claim traceable back to source data.”
Direct access to WHO and NIBSC reference panels for validation.
Pre-vetted clinical sites with strong IVD track records.
Every endpoint, every confidence interval — pre-specified, defensible, traceable.
Performance data accepted on review
An IVD manufacturer introducing a new diagnostic assay needed performance validation. We developed the Performance Evaluation Plan, prepared the PER, coordinated clinical study documentation, and reviewed analytical and clinical performance data.
Defined
Evaluation plan
Validated
Performance data
Accepted
Regulatory review
Submission-ready
PER dossier
Quick answers about scope, timelines, and how this engagement runs.
Ask us directlyPER is for IVDs and focuses on assay performance against comparators. Clinical investigations are for medical devices and assess clinical outcomes in patients.
Yes — all Class A–D IVDs in India require a PER. Complexity varies with risk class.
Often yes, if conducted under acceptable QMS. We assess existing data during discovery and only repeat what’s strictly necessary.
Through our NABL lab partners and reference biobanks. We handle all sourcing, characterization, and storage logistics.
PERs must be updated periodically — we offer retainer contracts for ongoing surveillance and PSUR reports.
A 30-min call clarifies sample size, lab selection, and timeline — at no cost.