Clinical Trials

Delivering precise renal pathology and FDA and GDPR-compliant CRO services to help sponsors move kidney disease therapies forward.

Research by Indication

At a glance

Years of experience

Annual biopsies

Dedicated employees

Behind every trial working toward better outcomes for kidney disease, precise pathology matters. That’s where we come in.

Our GCLP and GCP-trained staff, CAP, CLIA, HITRUST (e1), and New York State CLEP-certified laboratories, and advanced core research facilities enable us to partner with academic, pharmaceutical, and biotechnology institutions at all stages of research and development – from initial proof of concept through delivery of results.

Arkana Laboratories serves as a central biopsy processing lab for clinical trials, receiving more than 30,000 biopsies annually. Our team of 240+ employees is committed to the highest quality of clinicopathologic care, bringing unmatched concentration of renal pathology expertise to every study we support.

We partner with academic, pharmaceutical, and biotechnology institutions at every stage of R&D, and we do it through our FDA and GDPR-compliant CRO infrastructure with the security, discretion, and scientific rigor your program demands.

What Our Clinical Trials Division Offers

Central Pathology Services

Our central pathology team provides expert kidney biopsy evaluation for clinical trials, serving as the central processing laboratory for studies that require consistent, high-quality reads across multiple sites. Board-certified pathologists perform all reads using standardized protocols aligned to your study’s DTA requirements.

Board-certified pathologist overreads and primary reads
Tissue processing and staining (histochemical, immunohistochemical, enzymatic)
Light microscopy (H&E, PAS, Silver/JMS, Trichrome)
Immunofluorescence microscopy (IgG, IgA, IgM, C3, C1q, Albumin, Fibrinogen, Kappa, Lambda)
Electron microscopy with standardized imaging guidelines
Analysis, scoring, and reporting per study-specific scoring forms
Novel biomarker identification
Special stains and molecular testing (available upon request)

Operational & Logistic Support

Beyond pathology analysis, Arkana provides end-to-end operational and logistic support to keep your trial running smoothly. Our GCLP and GCP-trained staff and certified laboratory infrastructure ensure every step is audit-ready and compliant.

Whole slide scanning and digital image management
Study-specific clinical trial kit design and fulfillment
Data processing, transfers, storage, and archiving
Physician referrals — prospective and retrospective
Study-specific scoring forms developed to your DTA requirements
GCLP and GCP-trained staff throughout all trial phases
CAP/CLIA/NY CLEP-certified laboratory operations
HITRUST-certified data security and FDA/GDPR-compliant processes

Clinical Biomarker Center (CBC)

Arkana’s Clinical Biomarker Center (CBC) supports NIH-funded research, industry-sponsored studies, and internal R&D. As a certified partner with Akoya Biosciences in their CRO Partnership Program, we specialize in multiplex imaging of human tissues and offer contract research services for imaging and advanced image processing.

Akoya Polaris 9-color fluorescence and bright-field whole slide scanning microscopy with InForm spectral unmixing software
Halo AI image processing software with Halo Link for remote collaborations
Specialized modules for niche image processing projects
Leica laser scanning confocal microscopy for high-volume and high-resolution imaging
AI-based quantitative image analysis
Laser capture microdissection (pre-clinical)

Molecular Core Services

Arkana’s Molecular Core provides gene expression analysis and genotyping services to support biomarker-driven research and clinical trials. Our molecular capabilities are available in both pre-clinical and clinical trial phases.

NanoString nCounter assays — including the Banff Human Organ Transplant (B-HOT) panel and numerous gene expression panels
Digital PCR — SNP and copy number analysis
APOL1 risk allele genotyping, including validated non-invasive APOL1 testing
RNA/DNA extraction from FFPE, cells, and frozen tissue

Mass Spectrometry Core

NanoString nCounter assays — including the Banff Human Organ Transplant (B-HOT) panel and numerous gene expression panels
Digital PCR — SNP and copy number analysis
APOL1 risk allele genotyping, including validated non-invasive APOL1 testing
RNA/DNA extraction from FFPE, cells, and frozen tissue

Our Clinical Trial Services

Arkana’s clinical trials division offers a comprehensive suite of services spanning pre-clinical trial and clinical trial phases. Below is an overview of our current service offerings by category.

	Research Use	Clinical Use
Board-Certified Pathologist Reads
Novel Biomarker Identification
Stains (Histochemical, Immunohistochemical, Enzymatic)
Transmission Electron Microscopy
qPCR (SNP, Copy Number, and Gene Expression)
NanoString Assays
APOL1 Genotyping
RNA/DNA Extraction (FFPE, Cells, Frozen Tissue)
Whole Slide Scanning
AI-based Quantitative Image Analysis
Multiplex Immunofluorescence Microscopy
Confocal Microscopy
Histopathologic Processing and Scoring of Tissue Sections
Biomarker Expression Analysis
Laser Capture Microdissection to Isolate Tissue Compartments
Investigation of Therapeutic Target Selection
Physician Clinical Trial Referral Services
Mass Spectrometry

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