Expert-led IVDR strategy
- Intended use definition aligned to trial endpoints
- CE-marked versus laboratory-developed test (LDT) pathway assessment
- Risk-based validation planning from the outset
IVDR-Ready Specialty Laboratory Support for Clinical Trial Assays
Delivering regulatory confidence without slowing clinical progress.
Diagnostic and biomarker assays are woven through every phase of a modern clinical trial, from patient selection and stratification to safety monitoring and primary end points. For organizations developing in vitro diagnostics, ensuring your assay strategy aligns early with IVDR requirements is critical – not optional.
Under IVDR, the European Union’s regulation governing in vitro diagnostics (IVDs), assays supporting clinical decision-making face more rigorous requirements for performance evidence, risk classification, and regulatory oversight. A key challenge lies in aligning assay design, intended use, validation strategy, and evidence generation with regulatory expectations — a misalignment that can surface late in development, when the cost and impact of correction are highest.
We work with pharmaceutical and biotechnology sponsors, CROs, and IVD developers to address this challenge early through IVDR-compliant specialty laboratory services spanning assay strategy, intended use definition, and performance evidence generation.
Whether you’re transitioning from IVDD or launching a new program, our specialists can help you build an evidence strategy that supports IVDR requirements from the outset, helping reduce regulatory risk without slowing your trial down.
Why choose Cerba Research for IVDR-ready clinical testing?
Accredited specialty laboratories
- ISO 15189-accredited health institutions
- Proven inspection-ready quality systems
- Controlled execution under regulated conditions
End-to-end evidence generation
- Scientific validity, analytical performance, and clinical performance
- Performance Evaluation Report (PER)-ready datasets
- Documentation structured for regulatory scrutiny
Built for clinical trials
- Designed for enrollment, monitoring, and endpoint assays
- Sponsor- and CRO-friendly workflows
- No compromise on timelines or data usability
Two IVDR-compliant routes for clinical trial assays
Depending on assay availability and trial requirements, our sponsors typically follow one of two IVDR-compliant pathways.
Route 1: CE-Marked IVD Assays
CE-marked assays that comply with IVDR may be used in clinical trials when performed strictly according to the manufacturer’s validated instructions for use.
Key advantages:
Reduced regulatory complexity
Faster deployment within clinical protocols
High predictability during inspections and audits
Harmonized acceptance across EU Member States
CE-marked assays are strongly preferred for patient enrollment and primary endpoint determination, where the highest evidentiary standards apply.
Route 2: LDTs under Article 5(5)
Where no appropriate CE-marked assay exists, laboratories may develop and use in-house tests under the IVDR Article 5(5) exemption, provided strict conditions are met.
IVDR requirements include:
The laboratory qualifies as a health institution under EU or national law
Full demonstration of scientific validity, analytical performance, and clinical performance
Formal justification that no equivalent CE-marked assay is available
Robust technical documentation and ongoing compliance oversight
Cerba Research’s laboratories operate under ISO 15189 accreditation, enabling controlled, defensible execution of IVDR-compliant LDTs within regulated clinical trial environments.
From assay concept to IVDR-ready evidence
Access end-to-end Article 5(5) LDT expertise with integrated laboratory and regulatory-aligned support, across the full IVDR evidence lifecycle.
Assay strategy and design
- Intended use definition aligned to study objectives, patient populations, and clinical decision-making requirements
- Selection of appropriate technology platforms, including PCR, next-generation sequencing (NGS), immunoassays, flow cytometry, and mass spectrometry, based on assay complexity, throughput, and study needs
- Cross-functional scientific and operational input supporting assay feasibility, biomarker strategy, comparator planning, and workflow implementation
- Early alignment between assay design, protocol requirements, and study execution considerations to reduce delays and downstream rework
Analytical performance validation
- Design and execution of fit-for-purpose analytical validation studies tailored to enrollment assays, safety monitoring assays, and exploratory biomarkers
- Assessment of assay sensitivity, specificity, precision, reproducibility, stability, and reportable range under routine laboratory operating conditions
- Verification of assay robustness across operators, instruments, reagent lots, and sample types to support consistent performance throughout clinical studies
- Generation of structured validation datasets and supporting documentation for sponsor review and regulatory submission activities
Clinical performance and evidence generation
- Clinical performance studies supporting evaluation of assay concordance, clinical sensitivity, specificity, and intended use within defined patient populations
- Access to retrospective and prospective biospecimen collections supporting oncology, infectious disease, hematology, and advanced therapy programs
- Comparator method studies and equivalency assessments supporting assay optimization, bridging strategies, and transition into regulated clinical use
- Data generation workflows designed to support study milestones, evidence planning, and downstream reporting requirements
IVDR documentation and reporting
- Preparation of structured assay documentation including Performance Evaluation Reports (PERs), Scientific Validity Reports, validation summaries, and supporting technical records
- Compilation of evidence packages aligned to sponsor, CRO, and laboratory quality documentation requirements
- Support for risk assessments, traceability documentation, and technical file organization across the assay lifecycle
- Collaboration with sponsor and quality teams to facilitate audit readiness, documentation review, and submission preparation
Post-market obligations
- Ongoing assay performance monitoring and periodic review activities to support long-term consistency and compliance oversight
- Management of incident assessment, deviation investigations, and corrective action workflows within accredited quality systems
- Controlled change management processes covering assay updates, reagent changes, instrumentation adjustments, and workflow modifications
- Maintenance of supporting documentation, trend analysis, and surveillance activities throughout continued assay use
IVDR-compliant Centers of Excellence
Cerba Laboratory: Frépillon, France
Your trusted lab for IVDR-compliant specialty testing:
ISO 15189 accredited
Largest specialty laboratory in Europe
Over 50 years of diagnostic expertise
15+ years supporting CROs, biotechs, and IVD developers
High-throughput capacity exceeding 55,000 tests per day.
Technical expertise includes molecular diagnostics, immunoassays, flow cytometry, mass spectrometry, chromatography, and P3-level biosafety facilities supporting infectious disease, genetics, hematology, toxicology, and pharmacology.
Cerba Research: Netherlands (Cell and gene therapy)
We deliver IVDR-compliant AAV serology testing to support gene therapy clinical trials, identifying pre-existing anti-AAV antibodies that may impact safety, transduction efficiency, and clinical outcomes.
Current and planned capabilities include:
IVDR-compliant AAV9 ELISA
AAV8 and AAV9 MSD testing
ISO 15189 accredited execution.
These services support patient eligibility assessment, baseline immunogenicity profiling, and global trial feasibility.
Related specialized services
In-vitro diagnostics
End-to-end IVD support for diagnostic developers, combining regulatory insight, global operations, and robust evidence generation from concept through post-market compliance.
Assay development and technology transfer
Bespoke assays built around your program needs, then scaled and transferred seamlessly across laboratories, ensuring consistency, reliability, and readiness from preclinical research through to clinical delivery.
Biomarkers
Precision starts with the right biomarker. Unlock meaningful biological signals to guide patient selection, monitor response, and strengthen clinical endpoints across complex therapeutic landscapes.
On-demand webinar
Impacts of IVDR for Manufacturers and Users
In this webinar, scientists from Cerba Xpert, the IVD-focused branch of Cerba Research, explore what the shift to IVDR means in practice – from stricter compliance requirements to increased transparency and stronger post-market oversight.
We also look at how these changes are raising the bar for diagnostic quality and patient safety, while creating new challenges such as reclassification, resourcing demands, and potential disruptions during the transition.
Join us to understand what IVDR means for your organization and how to navigate this evolving regulatory environment.