Clinical Performance Evidence for IVDs & Diagnostic Devices
Bioexcel helps IVD manufacturers design and execute clinical performance programs using prospective participants, archived specimens, characterized samples, comparator methods, reference laboratories, lay users and regulatory-grade data analysis.
Our services connect clinical strategy, specimen feasibility, testing, data management, statistics and medical writing into one coordinated evidence program.
Does Bioexcel Conduct IVD Clinical Performance Studies?
Yes. Bioexcel supports IVD clinical performance studies including prospective recruitment, archived specimens, sample sourcing, comparator/reference testing, index-device testing, layperson studies, data management, biostatistics and final clinical performance reporting.
Bioexcel Lifesciences & Research LLP is a specialized medical device and IVD clinical research organization supporting diagnostic manufacturers with clinical performance studies, specimen sourcing, comparator/reference testing, lay-user studies, clinical data management, biostatistics and regulatory evidence documentation.
IVD Evidence Is More Than Running Samples
A robust IVD evidence program must align:
- Intended purpose
- Target condition
- Target population
- Specimen type
- Sample size
- Positive/negative distribution
- Disease prevalence
- Comparator method
- Reference standard
- Analytical performance
- Clinical performance
- User type
- Layperson use
- Sample stability
- Storage conditions
- Sample provenance
- Statistical analysis
- Performance Evaluation integration
Bioexcel therefore plans the study around the diagnostic claim and the evidence needed to support it.
From Diagnostic Claim to Regulatory Evidence
Intended Purpose & Regulatory Review
- Target analyte
- Target condition
- Intended user
- Specimen type
- Intended setting
- Regulatory market
- Existing evidence
Output: Defined Evidence Requirement
Clinical Performance Strategy
- Study design
- Population
- Sample type
- Comparator
- Positive/negative quotas
- Subgroups
- Acceptance criteria
Output: Clinical Performance Strategy
CPSP & Statistical Planning
- CPSP
- Objectives
- Endpoints
- Sample size
- Testing workflow
- Statistical methodology
Output: Study Documentation
Site / Sample Feasibility
- Sites
- Patient pools
- Sample availability
- Biobanks
- Reference labs
- Logistics
Output: Feasible Operational Model
Sample Collection / Procurement
- Prospective specimens
- Archived specimens
- Positive samples
- Negative samples
- Weak positives
- Rare subsets
Output: Qualified Specimen Cohort
Testing
- Reference testing
- Comparator testing
- Index-device testing
- Repeat/discordant testing
- Blinding where required
Output: Performance Dataset
Data & Biostatistics
- eCRF
- EDC
- Data validation
- Query management
- Sensitivity/specificity
- PPA/NPA
- Confidence intervals
Output: Validated Performance Evidence
Reporting & Regulatory Integration
- CPSR
- Clinical performance summary
- PER input
- PMPF input
- Regulatory response support
Output: Submission-Ready IVD Evidence
What IVD Study Types Does Bioexcel Support?
Bioexcel supports prospective clinical performance studies, retrospective archived-specimen studies, hybrid studies, layperson and self-testing studies, point-of-care studies, comparator studies and other diagnostic evidence programs depending on the intended use and regulatory objective.
What IVD services does Bioexcel provide?
Bioexcel provides IVD clinical performance study design, specimen feasibility and sourcing, reference testing coordination, layperson studies, clinical data management, biostatistics, CPSP and CPSR support.
What sample models can Bioexcel support?
Bioexcel can support prospective fresh-specimen studies, retrospective archived-specimen studies and hybrid programs where scientifically and operationally appropriate.
What regions can Bioexcel support?
Bioexcel supports IVD clinical performance programs in India and Europe through suitable clinical, laboratory and operational delivery arrangements.
Prospective Clinical Performance Studies
Bioexcel can support prospective recruitment where the study requires:
Study Requirements
- Fresh specimens
- Intended-use population
- Real clinical workflow
- Clinical diagnosis
- Point-of-care use
- Layperson use
- Self-testing
- Paired sample collection
Bioexcel Support
- Site feasibility
- Investigator selection
- Participant recruitment
- Consent process
- Sample collection
- Reference testing
- Index testing
- Monitoring
- Data management
- Statistics
- CPSR
Archived Samples for IVD Clinical Performance
Bioexcel can support retrospective studies where appropriately characterized stored specimens are scientifically suitable.
Potential Advantages
- Faster access to positive cases
- Rare analytes
- Controlled positive/negative distribution
- Access to pre-characterized samples
- Reduced prospective recruitment burden
Key Feasibility Variables
- Sample provenance
- Storage temperature
- Storage duration
- Residual volume
- Freeze-thaw history
- Reference result
- Sample age
- Clinical diagnosis
- Associated clinical metadata
Can Bioexcel Support Archived IVD Samples?
Yes. Bioexcel can assess and coordinate archived specimen programs where sample provenance, characterization, storage conditions, residual volume, ethical requirements and scientific suitability can be appropriately documented.
Combine Prospective and Archived Evidence
A hybrid design may be appropriate where:
- Common cases can be recruited prospectively
- Rare positives are difficult to recruit
- Specific subgroups are needed
- Archived samples can supplement target quotas
IVD Specimen Sourcing & Procurement
Bioexcel can assess feasibility for:
Sample Types
- Serum
- Plasma
- Whole blood
- Capillary blood
- Urine
- Saliva
- Nasal swabs
- Nasopharyngeal swabs
- Vaginal swabs
- Stool
- Other assay-specific specimens
Sample Categories
- Positive specimens
- Negative specimens
- Weak positives
- Near-cutoff samples
- High positives
- Disease controls
- Cross-reactive conditions
- Interference samples
- Serotype/genotype-defined samples
- Archived samples
- Fresh samples
Can Bioexcel Source Positive and Negative IVD Samples?
Bioexcel can assess availability of prospective or archived positive and negative specimens based on sample type, target condition, characterization method, residual volume, storage history, study quotas and regulatory requirements.
Biobank & Archived Sample Feasibility
Where external biobank material is considered, Bioexcel can evaluate:
- Sample type
- Disease status
- Reference characterization
- Sample volume
- Storage temperature
- Collection date
- Clinical metadata
- Ethics status
- Transfer conditions
- Shipment
- Testing suitability
Reference Testing Strategy
The comparator or reference method should be scientifically justified for the intended diagnostic claim.
Molecular
- PCR
- RT-PCR
- NAAT
- Sequencing where appropriate
Immunological
- ELISA
- Laboratory immunoassays
- Confirmatory serology
Microbiology
- Culture
- Microscopy
- Confirmatory microbiological methods
Toxicology
- LC-MS/MS
- GC-MS
Other
- Established laboratory analyzers
- Validated predicate methods
- Clinically accepted reference procedures
Can Bioexcel Arrange Comparator or Reference Testing?
Yes. Bioexcel can coordinate comparator and reference laboratory testing using scientifically justified methods appropriate to the intended diagnostic claim and study design.
Standardized Investigational Device Testing
Bioexcel can support a controlled device-testing workflow including:
- Test-lot tracking
- Operator documentation
- Blinding
- Reader/device output
- Invalid-result handling
- Repeat testing
- Discordant procedures
- Sample traceability
- Data capture
Layperson & Home-Use IVD Studies
Bioexcel supports studies where the intended user is not a healthcare professional.
- IFU comprehension
- Test setup
- Sample collection
- Device operation
- Timing
- Result reading
- Result interpretation
- Invalid-result handling
- User error
- Questionnaire
- User preference where relevant
Does Bioexcel Conduct Layperson IVD Studies?
Yes. Bioexcel can support layperson, self-testing and home-use IVD studies, including participant recruitment, device-use assessment, IFU comprehension, result interpretation, user questionnaires, data management and final reporting.
Point-of-Care Clinical Performance
The study design should reflect the intended user and clinical workflow. Potential settings may include:
Clinical Performance Metrics
Depending on the device and comparator, Bioexcel can support evaluation of:
Diagnostic Sensitivity and Specificity
Sensitivity
The proportion of reference-positive samples correctly identified by the investigational IVD.
Specificity
The proportion of reference-negative samples correctly identified by the investigational IVD.
Positive and Negative Percentage Agreement
When the comparator is not an accepted reference standard, agreement measures may be more appropriate.
PPA
Agreement among comparator-positive specimens.
NPA
Agreement among comparator-negative specimens.
The statistical terminology used should match the study design and comparator strategy.
Sample Size for Clinical Performance Studies
Sample size may need to be justified separately for:
Positive Cohort
Based on expected sensitivity or PPA and required precision.
Negative Cohort
Based on expected specificity or NPA and required precision.
Additional Cohorts
Weak positives, near-cutoff specimens, serotypes, genotypes, age groups, interfering conditions, cross-reactive conditions.
Can Bioexcel Calculate IVD Sample Size?
Yes. Bioexcel supports IVD sample-size planning based on the expected clinical performance, required statistical precision, confidence level, positive and negative cohort needs, subgroups and anticipated invalid or non-evaluable results.
Performance Around the Decision Threshold
For some assays, performance close to the cut-off can be particularly important. Bioexcel can support planning for:
Where such cohorts are required, the target distribution should be defined prospectively.
Clinically Relevant Diagnostic Subgroups
Some studies may require evidence across:
Bioexcel can incorporate subgroup quotas into specimen and statistical planning where appropriate.
Analytical Performance Planning
Depending on project scope, Bioexcel can support study planning, coordination and documentation for parameters such as:
CPSP Development
Bioexcel can develop or review a Clinical Performance Study Plan.
- Device description
- Intended purpose
- Study rationale
- Target population
- Target condition
- Study objectives
- Clinical performance endpoints
- Sample size
- Comparator
- Specimen strategy
- Testing workflow
- Blinding
- Data management
- Statistical analysis
- Ethics
- Monitoring
- Quality control
Can Bioexcel Prepare a CPSP?
Yes. Bioexcel can prepare or review Clinical Performance Study Plans for IVD studies, including specimen strategy, comparator methods, clinical performance endpoints, sample size, data management and statistical analysis.
Selecting Sites and Laboratories for Diagnostic Studies
Bioexcel feasibility may assess:
Clinical Site
- Target patient population
- Monthly recruitment potential
- Relevant medical specialty
- Sample collection
- Ethics pathway
- Study staff
Laboratory
- Reference methodology
- Laboratory infrastructure
- Sample processing
- Sample storage
- Quality systems
- Staff expertise
IVD Clinical Performance Studies in Europe
Bioexcel supports European IVD programs through appropriate local clinical and laboratory resources.
- European site feasibility
- Participant recruitment
- Archived specimens
- Reference testing
- Layperson studies
- Monitoring
- Data management
- Statistics
- CPSR
Can Bioexcel Support IVD Studies in Europe?
Yes. Bioexcel supports European IVD clinical performance programs through suitable local clinical and laboratory resources combined with centralized project management, data management, biostatistics and medical writing.
IVD Clinical Performance Studies in India
Bioexcel can support India-based programs involving:
- Clinical recruitment
- Fresh specimens
- Archived samples
- Site/lab feasibility
- Comparator testing
- Index testing
- Data
- Statistics
- Reporting
Can Bioexcel Conduct IVD Studies in India?
Yes. Bioexcel supports IVD clinical performance studies in India through suitable clinical sites and laboratories, including specimen feasibility, participant recruitment, testing, data management, statistics and reporting.
India, Europe or Hybrid Execution?
Bioexcel assesses the intended purpose, target market, population, user type and regulatory objective before recommending India-based, European or hybrid study execution.
Not every self-testing study can be conducted in India, and Indian data are not automatically accepted in Europe — regional suitability is assessed case by case.
IVD Data From Sample to Final Result
Potential data fields include:
- Participant ID
- Specimen ID
- Sample type
- Collection date
- Storage
- Reference result
- Index result
- Lot
- Operator
- Invalid tests
- Repeat tests
- Discordant tests
Every Specimen Should Remain Traceable
Bioexcel can support tracking across:
This is particularly important in archived-specimen and multi-laboratory studies.
IVD Statistical Analysis
Bioexcel biostatistical support may include:
Predefine How Discordant Results Will Be Managed
Discordant testing should not be improvised after the results are known. The study plan should define:
- What constitutes discordance
- Whether repeat testing is permitted
- Whether additional characterization is planned
- Which result is used in the primary analysis
- How discordant findings are reported
CPSR Development
Bioexcel can support preparation of the final study report.
- Executive summary
- Device description
- Intended purpose
- Study design
- Sites
- Participants/specimens
- Sample disposition
- Comparator
- Testing procedures
- Invalid results
- Clinical performance
- Sensitivity/specificity
- PPA/NPA
- Confidence intervals
- Subgroups
- Discordant results
- Limitations
- Conclusions
Can Bioexcel Prepare the CPSR?
Yes. Bioexcel can prepare Clinical Performance Study Reports using finalized clinical data, laboratory results and statistical outputs, with interpretation aligned to the study objectives and intended regulatory use.
Connect the Study to the IVDR Evidence Framework
The clinical performance study should feed into the broader Performance Evaluation.
Post-Market Performance Follow-Up
Bioexcel can support post-market performance evidence programs involving:
- Prospective data
- Retrospective data
- Additional specimen testing
- Literature surveillance
- User feedback
- Performance trends
- Real-world evidence
Clinical & Regulatory Documentation
Bioexcel can support:
- CPSP
- Study synopsis
- ICF/PIS
- CRF/eCRF content
- CPSR
- Performance Evaluation inputs
- PMPF documentation
- Regulatory responses
Why Diagnostic Manufacturers Work With Bioexcel
IVD-Focused Evidence Strategy
Study design starts from the intended diagnostic claim.
Clinical + Laboratory Integration
Clinical sites, sample sourcing and reference laboratories can be coordinated in one program.
Prospective + Archived Models
Flexible evidence generation based on sample availability.
Data + Biostatistics Integration
Performance data flow directly into statistical analysis.
India + Europe
Support for geographically flexible IVD programs.
Regulatory Documentation
CPSP, CPSR and Performance Evaluation support within the same evidence pathway.
Relevant IVD Evidence Programs
Frequently Asked Questions About IVD Clinical Performance Studies
An IVD clinical performance study evaluates how well an in vitro diagnostic device produces results associated with the target clinical condition or physiological/pathological state in the intended population.
Bioexcel connects clinical sites, specimens, reference testing, data, statistics and regulatory documentation into one IVD evidence program.