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Clinical Trial Services

Your specialty lab partner supporting clinical research

Integrating data from anatomic, cellular, and molecular investigations to provide clinical research teams with actionable information for patient monitoring and treatment decisions

Explore our solutions

Your specialty lab partner supporting clinical research

Integrating data from anatomic, cellular, and molecular investigations to provide clinical research teams with actionable information for patient monitoring and treatment decisions

Explore our solutions

Unparalleled expertise and knowledge in our field

We offer a unique combination of expertise that can be effectively applied to your clinical trial services.

Improving medicine through innovative science

Supporting more than

Clinical sites
worldwide
0

Over

0

Years

of Experience in Clinical
Trial Services

Clinical Trials Supported

Phase I-IV
0 +

Specialist Services

Solid Tumor Analysis

Advanced molecular profiling and precise biomarker studies drive targeted therapies in solid tumors, enhancing personalized treatment strategies for cancers including NSCLC, head and neck, prostate, breast and ovarian cancers

Hematological Malignancies

Cutting-edge diagnostics and precise classification transform the management of blood cancers, offering tailored insights for effective treatment planning 
in conditions such as AML, MDS, CLL, and multiple myeloma

GI Pathology

Expert analysis in GI pathology delivers accurate diagnostics for liver diseases, NASH, prostate cancer, ulcerative colitis 
and urological conditions, providing critical insights for effective patient management and treatment

Digital Pathology

Benefit from seamless access to digital slides, enhanced cost-effectiveness and simplify slide retrieval. By embracing digital pathology, your clinical trials can achieve new heights of efficiency and success.

Fully Integrated Approach

From specialty lab testing with seamlessly integrated project services and data management solutions to global logistics with specimen management support, our lab can provide centralized and harmonized services from any location worldwide.

*Subject to standard courier times

Our Solutions

Multiplex IHC clinical trial services

IHC and Multiplex IHC

Precise tissue analysis through immunohistochemistry and multiplex techniques for detailed insights

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Digital Pathology

Digital Pathology

Cutting-edge digital imaging for enhanced diagnostic accuracy and collaboration

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Genomic Solutions

Genomic Solutions

Advanced RNA, DNA, and liquid biopsy testing for personalized treatment strategies

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Cytogenetics FISH - clinical trial services

Cytogenetics & FISH

Comprehensive genetic testing to support targeted therapies and disease management

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Project Management & Data Management

Expert project & data managers support every stage of the project lifecycle 

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Global Logistics

Global Logistics

Integrated specialist logistics, sample management & custom kit building

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Project and Data Management

Our customer-focused clinical project and data managers provide dedicated support throughout the project lifecycle, keeping you informed and on budget at every important milestone. Our data management systems ensure secure, accessible, and integrated patient information across all services.

Project Management:

Dedicated teams for end-to-end project oversight.

Data Security:

Top-tier encryption and compliance with global standards.

Integrated Systems:

Streamlined data sharing for seamless access to patient data.

Client testimonials

“We are impressed with the team's effort, 
dedication, and professionalism and are confident that MPLN-Geneuity is the ideal partner for collaborating on these critical trials.”
Mid-Sized Pharma - Outsourcing Executive
“Of all the vendors currently supporting our global trials, MPLN-Geneuity is one of the most flexible, responsive, and easy to work with.”
Large Pharma Company – Director Biomarker Vendor Management
“MPLN-Geneuity is our go-to vendor for specialized pathology services. We appreciate the ongoing support on all our clinical trials.”
Mid-Sized Biopharma company - Senior Vendor and Operations Manager
“The pathology services provided by MPLN-Geneuity are crucial for our trials, and we consider your team as honorary members of our clinical development team.”
Director of Clinical Sciences – Mid-Sized Biopharma

Contact MPLN Biopharma Services

Call: +1 (865) 380-9746

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    Multiplex IHC clinical trial services

    IHC & Multiplex IHC

    Our advanced technology enables simultaneous visualization of single or multiple biomarkers within the same tissue section, delivering comprehensive insights and precise diagnostics. With unmatched expertise and cutting-edge technology, our team supports you in understanding complex tissue microenvironments, aiding patient stratification and treatment response prediction.

    Key Features

    • Simultaneously visualize multiple biomarkers within the same tissue section for deeper insights.
    • Advanced analysis of tissue microenvironments to assist in patient stratification and treatment response prediction.
    • Custom assay design and flexible testing to meet your unique research or clinical trial needs.
    • Our expert team provides detailed data analysis and interpretation to ensure accurate results.

    Benefits

    • Allows enhanced information from small biopsy samples. (I.e. NSCLC)
    • Gain comprehensive insights that lead to more precise diagnostics and better patient outcomes.
    • Enhanced ability to identify patient subgroups and better predict treatment responses more accurately.
    • Whether in biomarker discovery or clinical trials, our advanced technology supports a range of applications, helping you unlock the full potential of your tissue samples.
    Digital Pathology

    Digital Pathology

    Digital pathology revolutionizes clinical trials by enhancing accessibility, cost-efficiency, compliance, and data management. MPLN’s comprehensive digital pathology services streamline clinical research, allowing for improved patient outcomes and operational efficiency.

    Key Features

    • Seamless access to digital slides and slide retrieval enables instant access to digital slides.
    • Cost-effective digital slide management streamlines logistics by reducing the need for physical slide storage and transportation.
    • Digital storage ensures slides remain in perfect condition over time.

    Benefits

    • Allows key opinion leaders (KOL) and remote client pathologists to be utilized
    • Digital slides can be easily shared, allowing for faster, more collaborative decisions, including obtaining second opinions.
    • Reduces the costs associated with physical storage and transport of slides, improving trial efficiency.
    • Simplifies regulatory processes, ensuring quicker and more accurate FDA submissions and audit readiness.
    • Prevents slide degradation or breakage, maintaining the quality of research data for the long term.
    • Enables broader patient recruitment by facilitating decentralized clinical trials for wider geographic participation, increasing patient recruitment and diversity.
    Genomic Solutions

    Genomic Solutions

    Genomic medicine, a vital tool in oncology and drug development by providing deeper, more personalized insights into each patient.

    Beyond informing drug target discovery, validation, and clinical development, it uncovers critical genetic markers that drive disease progression and influence individual treatment responses. This empowers healthcare professionals to create more precise, tailored treatment plans, optimizing medical management based on each patient’s genetic profile.

    DNA Solutions – WGS*, WGMS*, WES*, TSO-500 Comp, Pillar OncoReveal
    RNA Solutions – Total RNA-Seq*, RNA exome*, mRNA*
    Liquid Biopsy Solutions – TSO-500 ctDNA, PGDx elio™ plasma complete*

    Key Features

    • Targeted NGS panels, including FDA-approved assays with companion diagnostic designations
    • Customized bioinformatics and reporting solutions 
    • Robust assay designs to accommodate low-yielding biopsy material
    • Streamlined wet lab processes to meet screening window timelines

    Benefits

    • Identify variants along with key biomarker signatures
    • Save time and money by assessing multiple biomarkers in a single test
    • Enable targeted therapies with actionable, easy-to-interpret results
    • Assists in targeted patient stratification and recruitment
    • Accelerates the development of personalized medicine

    *Offered through fully accredited partner laboratories.

    Cytogenetics FISH - clinical trial services

    Cytogenetics & FISH

    We offer a comprehensive range of chromosome analysis and fluorescent in situ hybridization (FISH) testing with industry-leading turnaround times and global coverage. Our board-certified lab directors and experienced cytogenetic technologists ensure accurate, efficient, and competitively priced testing with the highest quality of service.

    Key Features

    • Extensive FISH menu of over 40 loci and disease-specific panels detecting gene amplifications, deletions, translocations, and inversions.
    • Testing is available on bone marrow, blood, and FFPE tissue samples.
    • Specialized Offerings:
      • Plasma cell enrichment for plasma disorders
      • Stat turnaround for PML::RARA and acute myeloid leukemia
      • Bladder cancer urine analysis
      • Custom FISH assay development
    • Comprehensive chromosome analysis testing for oncology, infertility, recurrent pregnancy loss, and congenital disorders.
    • Global coverage of equivocal CAP/CLIA services supporting clinical trials

    Benefits

    • Rapid, precise results critical for diagnosis and treatment.
    • Expert-driven testing with Board-certified experts ensures the highest accuracy.
    • Tailored assays and solutions to meet unique clinical needs.
    • Faster diagnostics support timely treatment decisions.

    Project Management

    Our project managers have strong scientific backgrounds and extensive experience in complex research-based clinical trials. They collaborate with our scientific operations, client services, and commercial operations teams to deliver high-quality, regulatory-compliant testing results on time at every project step.

    Key Features

    • Each study is assigned a dedicated and experienced project manager
    • Studies are typically set up within 6 to 8 weeks of contract signature
    • Project management software tools ensure timely deliveries
    • Onsite customer service teams efficiently resolve queries and deliver reports

    Benefits

    • Accelerated study setup time
    • Responsive communication with the scientific and operational team
    • Testing completed on time and within budget
    • Prompt reporting of critical study data

    Data Management

    The key to a successful clinical trial is accurate, clean, quality data. Our team of data managers provides you with data in customized formats exported to your data management teams from our in-house laboratory information system (LIS).

    Key Features

    • Access to dedicated and experienced data specialists upon contract award
    • Customized reports are agreed upon in study-specific data transfer agreement
    • In-house software development team for custom data solutions
    • Flexible data exports and data transfers

    Benefits

    • Real-time reports for your data and project teams to aid in patient management
    • Guaranteed data integrity and quality
    • Improved decision-making and enhanced patient safety
    • Timely access to accurate, clean data for intermediate or final database lock
    Global Logistics

    Global Logistics

    Effective global logistics are the cornerstone of effective specialty laboratory testing supporting global clinical trials. With precious patient samples such as biopsy and bone marrow aspirates, ensuring samples reach the lab on time and within stability is paramount.

    Key Features

    • Partnerships with global specialist couriers and large integrators to support global studies and specialty shipping requirements
    • Ambient, refrigerated, frozen, and liquid nitrogen storage and shipment services available
    • Real-time or batched shipments based on your clinical trial’s individual needs
    • Secure, high-volume, redundant data storage solutions for digital pathology images
    • Expert advice for effective sample collection, handling, and transport
    • Accurate tracking and inventory for all clinical trial specimens

    Benefits

    • Safe and effective transport of specimens worldwide
    • Standardized procedures to reduce pre-analytical variability and ensure valid results
    • Centralized and harmonized specialty pathology testing supported
    • Reduced costs and maximized budgets with fully managed logistics from one trusted source
    • Readily available inventories, manifests, and shipments for timely study closeouts