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+971 425 44824

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Academic & Research Platforms

University & Discovery-Oriented Services

1.End-to-End Research Project Design

2.Scientific Positioning & Topic Strategy

3.Hypothesis & Research Question Engineering

4.Study Methodology & Experimental Workflow

5.Statistical Design & Power Analysis

6.Biomarker, Gene & Target Strategy

7.Assay Selection & Validation Planning

8.Translational & Regulatory Alignment

9.Risk Management, Quality & Reproducibility

10.Data Analysis, Reporting & Scientific Support

1.Neurology & Neuroscience

2.Metabolic & Endocrine Models

3.Cardiovascular & Stroke Models

4.Reproductive & Fertility Models

5.Immunology & Inflammation

6.Liver & Kidney Disease Models

7.Gastrointestinal & Microbiome

8.Regenerative & Wound Healing

9.Toxicology & Safety Models

10.Ocular & Retinal Disease Models

11.Respiratory Disease Models

12.Musculoskeletal & Arthritis Models

13.Urology & Renal Function Models

14.Ocular & Retinal Disease Models

1.Learning, Memory & Cognition

2.Anxiety & Stress Behavior Assessment

3.Depression & Motivation Behavior

4.Pain & Nociception Assessment

5.Motor Function & Coordination

6.Sensorimotor Integration & Reflexes

7.Seizure & Epilepsy-Related Behavior

8.Sleep & Circadian Rhythm

9.Social Behavior & Communication

10.Reward, Addiction & Motivation

11.Fatigue & Exercise Capacity

12.Gastrointestinal & Feeding Behavior

13.Metabolic & Energy Balance

14.Urinary & Bladder Function

15.Cardiovascular Function & Stroke

16.Regenerative Functional Readouts

17.General Activity, Locomotion

Clinical Monitoring

  • General Appearance & Condition
  • Behavior & Stress Indicators
  • Grooming & Coat Condition
  • Respiratory Patterns & Function
  • Toxicity & Distress Signs
  • Body Weight & Growth Monitoring
  • Food Intake & Nutritional Status
  • Hydration & Fluid Balance

Hematological & Biochemical

  • Complete Blood Count (CBC)
  • Clinical Biochemistry Panels
  • Electrolyte

1.Gene Expression (PCR-based)

2.Nucleic Acid Extraction & Synthesis

3.Design of Nucleotide Primer Sequences

4.PCR & Advanced Molecular Analysis 

5.DNA & RNA Quantification

6.Agarose Gel Electrophoresis Performance

7.Epigenetic and DNA Methylation Assays

8.Transcriptomic and RNA-Seq Analysis

9.CRISPR-Based Genetic Validation Assays

10.Protein Expression (WB)

11.Biomarker Quantification (ELISA)

1.Cell Line Preparation & Treatment

2.Cell Viability, Proliferation & Cytotoxicity

3.Cell Migration, Invasion & Angiogenesis

4.Flow Cytometry & Cell Fate Analysis

5.Oxidative Stress & Drug Response

6.Cell Labeling, Tracking & Differentiation

7.Imaging & Microscopy

8.Organ-on-a-Chip & Advanced In-Vitro Models

9.Advanced Cellular & Molecular Platforms

10.Protein, Antibody & Omics-Related Services

1.IHC, IF & TUNEL assay

2.Fluorescent Staining Techniques

3.Specialized Staining Techniques

  • Structural and Morphological Tissue
  • Fibrosis and Extracellular Matrix
  • Neurodegeneration & Neural Integrity
  • Metabolic Changes & Lipid Accumulation
  • Mineralization and Calcification
  • Vascular Structure and Elastic Fibers
  • Inflammation & Immune Response
  • Vital Function & Cellular Differentiation
  • Microbiological Staining Techniques
  • Microscopic Imaging Platforms

1.Quantitative Analysis & Reporting

2.Tissue Evaluation & Analysis

3.Qualitative & Semi-Quantitative Analysis

4.Scientific & Regulatory Support

1.Isolation, Culture & Identification

2.Biochemical & Phenotypic Characterization

3.Antimicrobial & Antibiotic Evaluation

4.Mechanism of Action & Antimicrobial Resistance

5.Applied & Industrial Microbiology Services

1.Plant Extraction

2.Plant Extract Drying

3.Essential Oil Synthesis

4.Nanoparticle Synthesis

5.Exosome Isolation

Visionofresearch

Preclinical-to-Clinical Biomarker Strategy

This comprehensive strategy package is engineered to systematically identify, validate, and translate robust biomarkers from preclinical models into actionable tools for human clinical trials. It directly addresses the modern regulatory mandate from the FDA and EMA for biomarker-driven development by building a scientifically defensible bridge between in vivo proof-of-mechanism and clinical decision-making.

Our process enables smarter trial design through data-driven dose selection and precise patient stratification, while providing the early proof-of-mechanism in humans that de-risks clinical investment.

The final output is a complete, regulator-ready biomarker dossier, including a prioritized translational shortlist, validated assay frameworks, and seamlessly integrated documentation for CTD submissions (Modules 2 & 4), equipping you to navigate the clinical pathway with confidence, efficiency, and compelling scientific evidence.

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    Veterinary Industry Innovation

    1

    Translational Correlation (In Vivo ↔ Clinical)

    This pivotal analysis assesses the validity and clinical applicability of biomarkers discovered in animal models. The workflow initiates with a systematic comparison of biomarker behavior in preclinical systems against established human data to confirm biological conservation. This is followed by a quantitative evaluation of each biomarker’s potential to predict therapeutic response or patient risk. The process culminates in the strategic alignment of biomarkers with defined clinical endpoints for Phase I/II trials, ensuring a direct link to measurable human outcomes. Core Framework:


    A) Cross-Species Bridging Analysis
         • Comparison of biomarker behavior in animal models versus known human data
    B) Predictive Value Assessment
        • Evaluation of biomarkers as predictors of clinical response or risk
    C) Clinical Endpoint Alignment
        • Mapping biomarkers to potential Phase I/II clinical endpoints

    Learn more
    Veterinary Industry Innovation

    2

    Clinical Assay Development & Optimization

    This phase transforms validated biomarkers into robust, reproducible analytical tools for clinical trial application. The focus is on establishing methods that are not only technically precise but also operationally fit for the clinical environment, accommodating limited sample volumes and rapid turnaround times. The ultimate goal is a “Validated Laboratory Method” capable of generating reliable data for pivotal trial decision-making.

    A) Assay Platform Selection

    • Optimal selection of the analytical platform (e.g., ELISA, multiplex, LC-MS/MS, or molecular assays) based on the biomarker’s nature, the clinical sample matrix (blood, plasma, tissue), and the practical requirements of the trial.

    B) Analytical Assay Development

    • Optimization of assay sensitivity and specificity for the reliable detection of the biomarker in complex human samples, overcoming challenges such as matrix interference.

    C) Assay Validation Parameters

    • Method validation per standard guidelines (e.g., ICH, CLSI) for key parameters including Accuracy, Precision, Linearity, Lower Limit of Quantification (LLOQ), and Upper Limit of Quantification (HLOQ) to ensure clinical applicability.
    Learn more
    Veterinary Industry Innovation

    3

    Biomarker Strategy for Clinical Development

    This service translates validated biomarkers into a strategic roadmap for their deployment across the clinical development lifecycle. We define the specific role and objective for each biomarker at each phase, ensuring they actively de-risk the program, generate critical evidence, and facilitate regulatory dialogue.

    A) Phase I Biomarker Integration

    • Strategic deployment of biomarkers to deliver early proof-of-mechanismin humans and provide a pharmacodynamic rationale for dose justification and selection.

    B) Phase II Biomarker Positioning

    • Application of biomarkers for efficacy monitoringto detect early signals of biological activity and to enable patient stratification for enriched, more powerful trial populations.

    C) Regulatory Communication Support

    Development of clear, compelling biomarker justification language for inclusion in IND/CTA submissions and to support strategic discussions in formal regulatory meetings.

    Learn more
    Veterinary Industry Innovation

    4

    Regulatory-Ready Biomarker Documentation

    This service packages all biomarker data and strategy into a cohesive, compelling, and compliant format designed for direct submission to regulatory agencies. We transform complex scientific findings into a clear narrative that meets regulatory expectations and supports the clinical development pathway.

    • Scope Note:This review establishes plausibility; it does not include clinical assay development or human validation.

    A) Translational Plausibility Review (Non-Clinical)

    • A critical assessment establishing the scientific rationale for translating a preclinical biomarker. This includes a cross-species relevance review(animal ↔ human literature), evaluation of theoretical detectability in standard clinical matrices, and a risk assessment for downstream translation.

    B) Biomarker Scientific Dossier

    • A comprehensive, standalone document compiling the complete scientific rationale, compiled preclinical validation data, and synthesized translational evidencefor the biomarker strategy.

     

    C) CTD Integration

    • Strategic placement of biomarker documentation within the Common Technical Document (CTD), specifically optimizing its location in Module 2 (Summaries)and Module 4 (Nonclinical Study Reports) to effectively create the nonclinical-to-clinical linkage for reviewers.

     

    D) Regulatory-Grade Figures and Tables

    • Generation of publication-quality, clear visual aids such as exposure-biomarker correlation plotsand translational correlation summary tables that effectively communicate key relationships and evidence to regulators.
    Learn more