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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 Translational Sciences team.

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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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=209924378674, hs_child_table_id=0, hs_updated_at=1774452297064, hs_published_at=1774960708819, description=Marlise Conrad is a Senior Clinical Trial Manager – Clinical Operations at Precision for Medicine, bringing more than 25 years of clinical research experience across CRA, start-up, and clinical trial management roles. She has over 17 years of experience as a Clinical Trial Manager, with prior experience as a CRA and global clinical lead, and a strong track record supporting multicenter Phase I–III clinical trials, including rescue studies. Marlise has extensive oncology experience across multiple solid tumor indications, including early-phase CAR‑T studies, and holds a Registered Nurse (RN) degree, which informs her patient-centered and detail-driven approach to trial execution., avatar=Image{width=5184,height=2920,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/marlise_conrad.jpg',altText='marlise_conrad',fileId=209132467611}, lastname=Conrad, hs_initial_published_at=1774452315067, hs_created_by_user_id=26433386, hs_created_at=1774452226032, hs_is_edited=false, hs_deleted_at=0, name=Marlise, job=Senior Clinical Trial Manager – Clinical Operations, slug=marlise-conrad, hs_updated_by_user_id=65160865}, second={}, third={}})
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    has third author: false, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1774960708819, description=John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, lastname=McIntyre, PhD, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757515873736, hs_is_edited=false, hs_deleted_at=0, name=John, job=Senior Director, Regulatory Strategy, slug=john-mcintyre, hs_updated_by_user_id=65160865}, second={hs_id=195821592097, hs_child_table_id=0, hs_updated_at=1757598947835, hs_published_at=1774960708819, description=An expert in hematology and oncology and a veteran of the FDA with almost nine years of experience, culminating as a Deputy Director for the Division of Hematologic Malignancies 2. Possesses a profound understanding of regulatory strategy, particularly in the development of CAR-T cell therapies, bispecifics and T-cell engagers. Spearheaded initiatives to develop novel endpoints in blood cancer such as minimal residual disease (MRD) in lymphoma and chronic lymphocytic leukemia (CLL.), avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Nicholas%20Richardson.png',altText='Nicholas Richardson',fileId=195817841672}, linkedin=https://www.linkedin.com/in/nicholas-richardson-do-mph-049784113/, team=[{id=163080551773, name='Clinical Solutions Leadership'}], lastname=Richardson, DO, MPH, hs_initial_published_at=1757528527317, hs_created_by_user_id=51739740, hs_created_at=1757528274871, hs_is_edited=false, hs_deleted_at=0, name=Nicholas, job=Vice President, Clinical Development, slug=nicholas-richardson-clinical-solutions, hs_updated_by_user_id=65160865}, third={hs_id=178046423372, hs_child_table_id=0, hs_updated_at=1754641388766, hs_published_at=1774960708819, description=Rosamund (Roz) Round is a seasoned expert in patient engagement and innovation bringing over 20 years of experience. She is focused on listening to and learning from patients and care partners to understand how to better improve trial access and experience. Roz successfully built and led decentralized clinical trials service through the pandemic and is now addressing the implementation of AI across various aspects of clinical research. She has a strong focus on diversity, equity, and inclusion (DEI) to drive health equity in clinical research. Roz holds an MSc in Health Psychology, studied Psychology and Immunology at Harvard University, and is a recognized thought leader with an extensive portfolio of publications, conference presentations, webinars, and vlogs., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Round-Rosamund.png',altText='Round-Rosamund',fileId=194123714174}, lastname=Round, hs_initial_published_at=1725972637852, hs_created_by_user_id=51739740, hs_created_at=1725972446462, hs_is_edited=false, hs_deleted_at=0, name=Rosamund, job=Vice President, PAtient Engagement & Innovation, slug=rosamund-round, hs_updated_by_user_id=65160865}})
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