Data Management

Data Management

Data Management

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

Key Features

  • Efficient Study Conduct – Streamlined data collection, cleaning, and processing with access to real-time report delivery to aid patient management
  • Data Quality – Accurate, consistent, and error-free data to meet your critical data transfer timelines
  • Regulatory Compliance – Databases and processes are 21 CFR Part 11, GDPR, and ISO 15189 compliant
  • Accountability – Audit trails available for clientsand regulatory authorities as needed

Benefits

  • Flexibility – Customized reporting and data solutions are agreed upon during study setup in data transfer agreements
  • Cost Savings – Minimized need for manual data entry and data QC due to automated process implementation
  • Competitive Advantage – Leverages data assets to drive innovation, improve decision-making, and enhance patient safety

The Data Management Process:

The Data Transfer Agreement (DTA) is at the core of our data management strategy. This essential document outlines the specifics of data delivery, ensuring that both parties are aligned on expectations.

Key elements of the DTA:

  • Delivery Format: We tailor the data format to match your needs, ensuring all specifications are met.
  • Data Security: We adhere to any standard required for the study, whether data encryption, password protection, or safe file transfer processes (sFTP).
  • File Naming Conventions: A clear file naming structure is established to streamline data identification.
  • File Transfer Frequency: A calendar for all data transfers throughout the study’s duration is established upfront to comply with data lock requirements.
Data Management

Data Quality Assurance Processes:

Our data management processes involve multiple layers of validation to ensure that the data delivered meets the highest standards.

  1. Setup Validation: Quality control scripts are written to verify that data from the Laboratory Information System (LIS) matches the required formats.
  2. Data QA Review: Comparison of source data and transferred data is conducted during the initial and subsequent transfers.
  3. Data QC Checks: Thorough checks using SQL queriesare performed, promptly alerting the project services team to any discrepancies prior to data delivery.

Once a data file passes all quality checks, it is securely transferred according to the DTA specifications.

The Impact of Geneuity’s Data Solutions: Innovation in Healthcare:

Ultimately, our Data Management efforts provide clients with efficient study content, high-quality data, regulatory compliance, accountability, scalability, cost savings, and a competitive advantage in the clinical trial landscape. Examples of how our data services have made a significant impact on the biopharma sector include:

  1. Ongoing Safety Evaluation
    Real-time report availability and close project management oversight play crucial roles in the ongoing assessment of patient safety when treated with innovative gene therapies.
  2. Groundbreaking Research Publications
    A recent study featured whole-slide digital images from the MPLN laboratory, paving the way for therapies targeting novel overexpressed biomarkers.
  3. FDA Approval Success
    Pathology data helped a major biopharma client secure FDA approval for a revolutionary treatment for Crohn’s Disease.
  4. Pioneering Cancer Trials
    Critical pathology data demonstrated the efficacy of a novel therapeutic in CLL and SLL, leading to new indications and driving improved patient outcomes.
  5. Driving IVD Innovations
    Molecular data has been pivotal in multiple IVD studies, leading to FDA approval of various assays in women’s health and infectious diseases.

Our Data Management team excels in delivering real-world data that supports effective disease solutions, ensuring our clients remain at the forefront of healthcare advancements.

Cytogenetics

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Molecular Pathology Laboratory Network

    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 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.

    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.
    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.

    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.
    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.