Clinical Trial Support

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Molecular Pathology Laboratory Network

MPLN Offers Complete Clinical Trial Support

With over two decades of experience and over 400 Phase I-IV research studies completed, our experienced team of scientists and pathologists produces top-quality results through appropriate regulatory-compliant testing, evidenced by our stringent adherence to CAP/CLIA, ISO 15189 accreditation, and state licensures. Our committed team of project and data managers diligently ensures the timely delivery of data for complex trials to achieve patient recruitment targets and to support the preparation of a successful FDA submission packet, minimizing rejection risks while reducing overall study costs. With our main laboratory strategically located in East Tennessee, we partner with a trusted and accredited network of laboratories across the globe to support global studies, providing centralized and harmonized testing solutions.

Geneuity Clinical Research Services

Geneuity Clinical Research Services

Geneuity Clinical Research Services is a DBA wholly owned by Molecular Pathology Laboratory Inc (MPLN) that encompasses the following branches, providing services specifically tailored to our Biopharma and Clinical Research clients: Project Management, Data Management, and Commercial Operations. The MPLN laboratory performs all specimen handling and testing as a CAP/CLIA/ISO15189 accredited laboratory. 

Therapeutic Expertise

We offer targeted diagnostic approaches to fulfill the specific requirements of clinical trial studies. Our pathologists and scientific experts have extensive knowledge and experience in a wide range of therapeutic areas including solid tumor oncology, Non-Small Cell Lung Cancer, head and neck cancer, prostate cancer, breast cancer, ovarian cancer, dermatopathology, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, Multiple Myeloma, GI pathology (liver, NASH, cytology, urology), hematopathology, and more. We proudly have three board-certified hematopathologists on staff and scientific experts supporting infectious disease, immunology, inflammatory response, genetic and rare diseases, and musculoskeletal, pulmonary, and sepsis indications. We further expand our network of experts using our trusted KOL partners.

Cytogenetics
Clinical Trial Support - TLS multiplex panel

Extensive Test Menu

Our expert board-certified pathologists and scientists can help assess biomarkers and complex molecular pathology testing panels for patient recruitment, stratification, and ongoing safety monitoring. Our team also offers fully customizable validation services across all testing areas to support novel and exploratory biomarker assessments. Our combination of experience as a trusted CAP/CLIA laboratory and full-service validation capabilities provides a consultative and unique approach to clinical trials, including R&D and IVD study laboratory testing. Please browse our extensive testing menu to see our full selection of validated diagnostic and exploratory assays, or contact us today for questions about validation services.

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    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
    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 unique 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.
    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.

    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.
    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
    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.

    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.
    • Detailed data analysis and interpretation are provided by our expert team 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 with greater accuracy.
    • 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.
    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.

    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.