Preclinical Research and
Regulatory Services
Life science innovators
come to CNC Path Lab
Ready to accelerate your clinical program? Our experts are here to help you design and execute the perfect laboratory strategy. Are you ready?
Solutions to Guide Your Project to Clinical Phases
Expertly designed preclinical services to ensure a seamless transition from discovery to clinical validation.
Biomarker Discovery and Target Validation
Identifying and validating novel biomarkers to support target selection and accelerate your preclinical programs.
Specialty Assay Development
Custom assay design, optimization, and validation tailored to your specific therapeutic mechanisms and goals.
Biomarker Strategy
Comprehensive planning and implementation of biomarker strategies from preclinical research through clinical phases.
Companion Diagnostics Program
Early-stage development and strategic alignment for future companion diagnostic (CDx) integration.
Specialty Assay Development
Precision supports preclinical development with advanced biomarker assay solutions, specializing in large molecule bioanalysis and immunogenicity testing. Our expertise includes:
Immunogenicity assessment
Neutralizing and total antibody (NAb/Tab) assays
Pharmacokinetic (PK) assays
Tissue analysis using Immunohistochemistry (IHC) and Multiplex Immunofluorescence
Sensitive analyte detection through ELISA, Luminex, and Meso Scale Discovery (MSD) platforms
Viral tissue distribution analysis for gene therapies using ddPCR and qPCR
Evaluation of gene editing accuracy and specificity through Next-Generation Sequencing (NGS)
Biomarker Strategy: Planning Biomarker Analysis for Clinical Trials
Effective biomarker planning plays a vital role in the success of clinical trials. Integrating biomarker management with clinical trial operations from the beginning helps ensure efficient execution, high-quality data collection, and smoother study workflows.
Before starting a clinical trial, key biomarker sampling details should be clearly defined, including sample type, processing and handling methods, collection frequency, and intended data usage.
Well-planned biomarker strategies help improve the overall effectiveness, accuracy, and reliability of clinical trial outcomes.
Informed Consent
Informed consent forms (ICFs) should clearly outline sample collection requirements and any associated risks to ensure participants are fully informed before enrollment.
Sample Kits
Sample kits must be prepared and delivered to clinical sites before the first patient enrollment to ensure accurate sample collection, handling, and processing procedures are properly followed.
eCRF
Development and structuring of the electronic case report form (eCRF) to ensure smooth and standardized data capture
Site Budgets
Site budgets may be affected by the type of biomarker samples collected and the frequency of sample collection throughout the study.
Data Management
Biomarker data management enables data from multiple laboratories to be integrated with clinical data, helping generate more accurate and meaningful insights.
Advanced Companion Diagnostic Programs
We help develop companion diagnostic solutions from research to clinical use with expert support at every stage.
- Biomarker assay development
- Indications and claims planning
- Diagnostic product design support
- FDA and regulatory pathway guidance
- Point-of-care, lab, and home testing strategies
- CLIA and quality compliance support
