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Clinical Sample Data Services and Data Management

Precision designs processes for all aspects of clinical patient sample data to ensure clinical study integrity
A key aspect of central lab services, and management of clinical patient samples, is the data associated with those samples. Precision understand the needs of complex and biomarker-driven clinical trials and has built processes and teams to provide comprehensive support.

Accurate data for all aspects of clinical patient samples are crucial for the integrity of any clinical study

The greater the study complexity—driven by multiple sample types and timepoints being collected, sample processing, or challenging logistical process—the greater the chance for inaccurate data and an inaccurate view of the state of the clinical study samples. Precision’s dedicated team and purpose-built systems safeguard all aspects of sample data integrity and data quality through creation of database parameters and data handling requirements to fit sponsor and study needs. Data management is enabled and enhanced by key Precision technologies: PrecisionLIMS, and the Precision Lab e-Portal powered by QuartzBio®.

Precision ensures accurate data with connected processes

Study Startup

Generation of data transfer agreements/global data management plans, database setup, kitting design support, and more.

Data Reconciliation and Discrepancy Resolution

Support of all reconciliation activities based on EDC readouts, client data inquiries, oversight on discrepancy resolution process and subsequent data updates, and more.

Sample Operations Oversight

Proactive data screening at study level, assay test tracking at sample level, blinding plan conformance.

Established workflows provide confidence in data integrity

Precision’s Biospecimen Data Services team utilizes processes with discrete steps for data cleaning, data checks, and modification as needed. Data is then available to sponsors through the Precision Lab e-Portal. This ensures that study sponsors have rapid access to clean, accurate data and always know the true status of their studies.

biospecimen data services workflow

Enabling technologies and features

Planning and designing the optimal route and managing couriers when samples need same-day processing is challenging. Precision’s knowledge in logistics and shipment processes means kits are sent directly to clinical sites and collected samples quickly arrive at Precision or other facilities for processing, analysis, or storage.

PrecisionLIMS

LIMS, including paperless and real-time documentation and built-in QC steps and digital verifications

Precision Lab e-Portal

Online systems providing 24/7 access to sample inventory reports, kit inventory, status reports, and shipment status

 

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Related Services

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    kitting

    Clinical Sample Kitting & Logistics

    Kit production, clinical site training, and full sample shipment logistics
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    biospecimens

    Biostorage

    Sample storage under all conditions and temperatures, rapid sample accessioning, and online inventory access

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    Precision Lab e-Portal

    Real-time visibility into project, sample, kit, and shipment status provides 24/7 access to critical study data
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Explore the Precision blog

Read our blog to gain more insights and discover work that Precision has supported.

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778891, hs_child_table_id=0, hs_updated_at=1709645745122, hs_published_at=1748379090824, description=Kurt Preugschat has over 11 years of statistical experience from Phase I to Phase IV clinical trials. He is a lead statistician, providing statistical support and oversight for numerous clinical trials associated with new drug applications (NDA), supplemental new drug applications (sNDA), and medical devices. His expertise includes the development of study designs to meet complex clinical questions and the measurement of desired outcomes. In addition, Kurt has extensive experience generating statistical analyses and creating complex SAS programs and macros used by study team., avatar=Image{width=150,height=150,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/kurt-preugschat.webp',altText='',fileId=null}, linkedin=https://www.linkedin.com/in/kurt-preugschat-97298923a, hs_name=, hs_path=, lastname=Preugschat, hs_initial_published_at=1716136551646, hs_created_at=1709645745122, hs_is_edited=false, hs_deleted_at=0, name=Kurt, job=, slug=kurt-preugschat, email=, hs_updated_by_user_id=51739740}, second={}, third={}})
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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=187570680222, hs_child_table_id=0, hs_updated_at=1742413198455, hs_published_at=1748379090824, description=Christine has been ensuring high performance delivery of clinical research projects for more than 23 years. During this time, she has successfully led diverse teams across various cancer indications including renal, pancreatic, melanoma, lung, head and neck, breast, multiple myeloma, extra-nodal NK/T lymphoma, non-Hodgkin’s lymphoma, and Hodgkin’s lymphoma. Within the CRO setting she also supported the strategic development of over 50 hematology/oncology programs including complex Phase 1 projects in immuno-oncology and autologous cell therapy. She also led the establishment of a novel oncology research infrastructure which accelerated study activations for Phase 1 solid tumor studies. Christine obtained her master’s degree in public health at the University of Texas where she also trained in the development and implementation of clinical and epidemiologic research at the Coordinating Center for Clinical Trials as well as the Center for Occupational and Environment Health., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christine%20Lusk-1.png',altText='Christine Lusk-1',fileId=187579105870}, lastname=Lusk, hs_initial_published_at=1742410730688, hs_created_by_user_id=26433386, hs_created_at=1742410650472, hs_is_edited=false, hs_deleted_at=0, name=Christine, job=Director, Project Management, slug=christine-lusk, hs_updated_by_user_id=51739740}, second={hs_id=190691157084, hs_child_table_id=0, hs_updated_at=1748379058655, hs_published_at=1748379090824, description=Over the last 15 years, Megan has played a key role in advancing multiple oncology compounds through various stages of development, across numerous tumor types. Having worked at both biotech and CRO companies, Megan brings a comprehensive understanding of clinical operations and drug development. Megan maintains a focus on accelerating the development of innovative cancer therapies to improve patient outcomes worldwide., avatar=Image{width=3024,height=4032,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Megan%20Knoch.jpg',altText='Megan Knoch',fileId=190688034156}, lastname=Knoch, hs_initial_published_at=1748379090824, hs_created_by_user_id=26433386, hs_created_at=1748379018316, hs_is_edited=false, hs_deleted_at=0, name=Megan, slug=megan-knoch, hs_updated_by_user_id=26433386}, third={}})
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