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Bioanalytical CRO Services
Move beyond routine biomarker testing with a structured bioanalytical qualification program. Eve Technologies provides assay and platform strategy, fit-for-purpose analytical qualification, formal study documentation and subsequent study sample analysis across ELISA, MSD and Luminex platforms.
Our CRO services are designed for research, translational and drug-development programs requiring documented assay performance before larger-scale study sample analysis.
Eve’s experience goes beyond the scale of the work completed. Biomarker analysis has been at the core of our laboratory for more than two decades, supporting projects across academic research, biotechnology and pharmaceutical development. Today, that experience underpins our CRO services, with dedicated project management and analytical testing performed in-house from qualification through study sample analysis.
Have a Question or a Project in Mind?
Tell us a few details about your project and our team will follow up to discuss the next steps.
Prefer to contact us directly?
Analytical Expertise Behind Every Program
Our CRO services are built on extensive experience in high-throughput biomarker testing and analytical performance characterization. Beyond our research services, Eve also operates a CLIA-certified clinical laboratory, bringing additional experience in rigorous laboratory quality practices, documentation and analytical performance.
With dedicated scientific project management and all analytical testing performed in-house, your program stays with one experienced laboratory team from qualification through study sample analysis.
Discovery Testing vs. CRO Qualification
Not every biomarker study requires formal analytical qualification. Eve continues to provide routine Discovery testing for research programs requiring high-quality biomarker measurement without prospective analytical qualification.
For programs requiring documented assay performance, our CRO services provide purpose-designed analytical studies and formal qualification before study sample analysis.
| Routine Discovery Testing | Bioanalytical CRO Qualification | |
|---|---|---|
| Objective | Generate reliable research biomarker data | Establish and formally document assay-specific analytical performance |
| Optimization | Performed as needed to support testing | Prospectively defined and documented |
| Performance characterization | Routine QC / observed assay performance | Purpose-designed analytical studies defined by the selected package |
| Documentation | Results workbook and assay comments | Qualification plan/protocol + supporting data + formal qualification report |
| Next step | Research interpretation | Study sample analysis under the established analytical conditions |
Routine Research Testing
Need reliable biomarker data without a formal qualification program? Choose from Eve Technologies’ established Discovery Assays, send your samples, and receive quantitative results for your research.
Bioanalytical CRO Program
Need greater analytical characterization and documentation before study sample analysis? Our CRO services add a structured qualification process to establish and document assay performance, followed by study sample analysis under the established analytical conditions.
Qualification Service Levels
| Service Component | Essential | Enhanced | Comprehensive |
|---|---|---|---|
| Dedicated project management | Included | Included | Included |
| Assay & platform strategy | Included | Included | Included |
| Sample optimization & dilution strategy | Included | Included | Included |
| Intra-assay precision (CV) | Included | Included | Included |
| Inter-assay precision (CV) | Included | Included | Included |
| Analytical range: sensitivity | _ | Included | Included |
| Analytical range: LLOD | _ | Included | Included |
| Analytical range: LLOQ | _ | Included | Included |
| Analytical range: ULOQ | _ | Included | Included |
| Direct reference interval study: central 95% | _ | _ | Included |
| Accuracy (spike recovery) | _ | _ | Included |
| Qualification plan / protocol | Included | Included | Included |
| Formal qualification report | Included | Included | Included |
Essential — Core Analytical Performance
Establishes the analytical conditions required for consistent study execution, including sample optimization and dilution strategy, intra-assay precision and inter-assay precision.
Enhanced — Expanded Analytical Performance
Includes all Essential components plus accuracy by spike recovery and analytical range characterization, including analytical sensitivity, LLOD, LLOQ and ULOQ.
Comprehensive — Expanded Qualification + Reference Interval
Includes all Enhanced components plus a direct reference interval study using a defined reference population to establish the central 95% reference interval. The reference population, sample number and study design are defined or approved by the client.
Additional Fit-for-Purpose Studies
Qualification programs can be tailored to the assay, sample matrix and intended application. Where appropriate, additional studies can be incorporated beyond the standard qualification packages, including:
- Cross-reactivity
- Interference
- Selectivity
- Sample and analyte stability
- Additional assay-specific performance assessments
These studies can be incorporated into the qualification plan based on project requirements.
Qualification Deliverables
Each qualification program provides clear documentation of the work performed and the analytical performance established.
Dedicated project management
Coordination of qualification activities, study requirements and timelines.
Qualification plan / protocol
A study-specific protocol defining the assay, experimental conditions, qualification parameters and applicable acceptance criteria.
Analyte-level performance specifications
Documented analytical performance for individual biomarkers based on the completed qualification studies.
Formal qualification report
A consolidated report documenting the qualification methods, results and performance assessment.
Transition to sample analysis
Following qualification, established assay conditions can be carried forward into analysis of the study cohort.
Supporting Research, Translational and Drug-Development Programs
The analytical requirements of a biomarker assay depend on its intended use. Our CRO services provide a structured framework for establishing and documenting assay performance to support programs progressing beyond exploratory research and into translational and regulated drug development.
Because qualification and validation needs vary from one study to another, we support our clients with assay feasibility, platform strategy, qualification design and laboratory execution. The client remains responsible for determining the scientific and regulatory requirements that apply to the intended use.
Have a Question or a Project in Mind?
Tell us a few details about your assay, sample matrix and program requirements. Our team will follow up to discuss the appropriate analytical scope and next steps.
Prefer to contact us directly? Reach us at contact@evetechnologies.com