Clinical Trial & Performance Study Support for IVD Projects
Support for clinical study strategy, international clinical pathways, study documentation, data management and statistical analysis across major target markets.
From Study Strategy to Structured Clinical Evidence
Clinical evidence connects the intended use of a diagnostic product with data demonstrating how it performs in relevant clinical populations, specimen types and use conditions.
Study requirements can vary according to the target market, regulatory pathway, intended purpose, specimen source, comparator method and overall study design.
EXIMIO's clinical support can be configured around study planning, documentation, data management, statistical analysis and regulatory-oriented clinical reporting according to the current project stage.
Define the clinical question and intended evidence.
Structure population, specimens and comparator strategy.
Organize clinical data collection and database control.
Convert study data into interpretable clinical evidence.
Good Clinical Practice Across the Study Lifecycle
Good Clinical Practice provides an ethical and scientific quality framework for the design, conduct, monitoring, documentation, analysis and reporting of clinical research.
A structured clinical workflow helps maintain study integrity while supporting data that is traceable, reviewable and suitable for subsequent clinical and regulatory evaluation.
Protocol Design
Define study objectives, methodology, population, procedures, endpoints and analysis considerations before study initiation.
Ethical Review
Address protection of study participants, ethical oversight and applicable informed-consent requirements.
Study Conduct
Conduct clinical activities according to the approved study protocol and defined responsibilities.
Monitoring
Review study conduct, protocol compliance and clinical records throughout the study lifecycle.
Data Integrity
Maintain clinical information that is accurate, complete, consistent and supported by appropriate source documentation.
Analysis & Reporting
Apply predefined analytical methods and organize study results into clear, reviewable clinical reports.
Clinical Study Considerations by Market
Select a target market to review its main clinical pathway, study considerations and regulatory framework.
FDA Medical Device Clinical Study Pathway
Clinical investigations of medical devices in the United States are considered within the FDA Investigational Device Exemption framework, with different requirements depending on the study and device risk.
Risk-Based Clinical Study Management
The applicable clinical investigation pathway should be considered before study initiation, including whether the investigation falls under an IDE exemption or involves a significant-risk or nonsignificant-risk device.
Significant-risk investigations generally involve FDA and Institutional Review Board review before initiation, while nonsignificant-risk studies may proceed under abbreviated IDE requirements following the applicable IRB process.
From Risk Determination to Study Reporting
Consider IDE applicability and the SR / NSR status of the proposed investigation.
Establish the applicable regulatory and ethics review requirements before study initiation.
Follow approved protocol, informed-consent and monitoring requirements during the investigation.
Maintain study records and complete applicable FDA and IRB reporting requirements.
Key Areas for Clinical Investigation Planning
IVD Clinical Performance Study
Clinical performance studies can generate clinical performance evidence when relevant device performance cannot be adequately established through analytical studies, literature or previous diagnostic experience alone.
Clinical Evidence Within Performance Evaluation
Clinical performance information contributes to the overall performance evaluation of an IVD and supports evaluation of whether the device achieves its intended clinical performance.
Clinical performance studies should be designed to generate relevant evidence while controlling potential bias and documenting study methods, results and conclusions.
From Evidence Need to Performance Study Report
Determine the clinical-performance question requiring additional evidence.
Establish the Clinical Performance Study Plan, objectives, methods and analysis strategy.
Perform the study according to the approved plan and applicable ethical and regulatory requirements.
Document study methodology, results, deviations and conclusions within the final study report.
Core Elements of Clinical Performance Study Planning
TGA Clinical Trial Pathways
Clinical trials involving unapproved therapeutic goods in Australia may proceed through the Clinical Trial Notification or Clinical Trial Approval pathway depending on the product, evidence package and proposed investigation.
CTN and CTA Clinical Trial Pathways
Under the CTN pathway, responsibility for scientific and ethical assessment principally sits with the relevant institutions and Human Research Ethics Committee, with the trial notified through the applicable TGA process.
The CTA pathway includes submission of supporting product information for assessment before the applicable clinical trial proceeds.
From Pathway Selection to Trial Completion
Consider whether the CTN or CTA pathway is appropriate for the proposed clinical trial.
Complete applicable scientific and ethical review of the proposed investigation.
Complete the applicable CTN notification or CTA application process.
Conduct the study and complete applicable study reporting and trial completion requirements.
Key Areas for Australian Clinical Trials
Clinical requirements depend on the product, intended use, target population, specimen type, study design, risk profile and target market. The applicable pathway should therefore be evaluated at the project level before study initiation.
From Study Records to Structured Clinical Evidence
Clinical data services can support studies approaching the end of enrollment as well as projects requiring dedicated data-management or statistical-analysis support.
Data workflows can be structured from CRF and database development through data review, database lock, statistical analysis and final reporting.
Clinical Data Management
Support the organization, review and controlled delivery of clinical study data.
- CRF design
- Database establishment
- Database testing and validation
- Data management plan
- Data verification plan
- Data entry and consistency review
- Programmatic data checks
- Clinical data review
- Query generation and resolution
- Data management progress reporting
- Blind data review
- Database lock
- Data extraction and transfer
- Data management report
- Final data delivery
Statistical Analysis Support
Apply statistical planning and analysis to support interpretation of clinical study results.
- Statistical analysis plan
- Statistical input to study protocols
- Statistical regulatory support
- Sample-size estimation
- Power calculations
- Interim statistical analysis
- Final clinical data analysis
- Independent statistical analysis report
Connecting Strategy, Study Execution and Data
Clinical activities can be connected into a structured evidence pathway according to the requirements of the project.
Define target market and clinical evidence objective.
Define study population, specimens and methodology.
Conduct clinical activities under the applicable framework.
Review and organize study data.
Apply predefined statistical methods.
Organize results for clinical and regulatory use.
Support According to Your Current Study Stage
Clinical projects can enter the workflow at different stages. Support can therefore focus on individual activities rather than requiring a complete end-to-end clinical program.
Clinical Strategy
Review target-market considerations and define the intended clinical evidence.
Study Planning
Support clinical study objectives, methodology and key protocol elements.
Clinical Documentation
Organize study-related clinical and supporting documentation.
Data Management
Support CRF, database, data review, query and database-lock activities.
Statistical Analysis
Support sample-size planning, analytical methods and statistical reporting.
Clinical Reporting
Structure study methodology, data, results and conclusions into reviewable reporting materials.
Planning Clinical Evidence for Your IVD Project?
Tell us about your target market, intended use, study stage and available clinical data. Our team can discuss a clinical-support approach based on your project requirements.