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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 clinical logistics 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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Read: Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

Clinical Trials - Early Phase Research - Autoimmune

Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

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    has third author: false, (SizeLimitingPyMap: {main={hs_id=214928090133, hs_child_table_id=0, hs_updated_at=1781285625399, hs_published_at=1781285742914, description=Deborah Spencer is a Senior Director of Project Management at Precision for Medicine with over 25 years of experience in clinical research. She specialises in leading global clinical trials across multiple phases, with deep expertise in complex study delivery. Deborah provides strategic oversight of programmes, leads high-performing teams, and partners closely with sponsors to ensure successful execution and regulatory readiness., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Deborah%20Spencer.jpg',altText='Deborah Spencer',fileId=214838919278}, lastname=Spencer, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285562019, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Senior Director, Project Management, slug=deborah-spencer, hs_updated_by_user_id=26433386}, second={hs_id=214928170660, hs_child_table_id=0, hs_updated_at=1781285676367, hs_published_at=1781285742914, description=Anthea Gates is a Project Director with approximately 30 years of drug development and medical device industry expertise across all phases, over a variety of indications including breast, lung cancer, solid tumors and lymphoma, cutaneous T-cell lymphoma, malignant melanoma, squamous cell carcinoma, rare haematologic disease, autoimmune rheumatology, osteoarthritis, ocular burns, liver cirrhosis, myopia and pre-eclampsia. Committed to delivering quality and passionate about building positive relationships with clients and study teams to promote cohesive business practices and ensure the successful management of projects from start to finish. Anthea holds a proven track record in effective leadership of cross-functional teams across programs of studies, to the accomplishment of operational excellence., avatar=Image{width=372,height=546,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/profile.jpg',altText='profile',fileId=214846873938}, lastname=Gates, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285639221, hs_is_edited=false, hs_deleted_at=0, name=Anthea, job=Project Director, slug=anthea-gates, hs_updated_by_user_id=26433386}, third={hs_id=214928090141, hs_child_table_id=0, hs_updated_at=1781285738567, hs_published_at=1781285742914, description=Claire Delaville is a Senior Project Manager at Precision for Medicine. She brings 18 years of experience across preclinical and clinical research, including more than a decade leading Phase I to IV studies in oncology, rare diseases, and immunology, with direct experience in first-in-human and multicenter oncology trials. Claire is responsible for maintaining study quality through inspection readiness, corrective action planning, and proactive risk mitigation. She also oversees study budgets and vendor performance to support coordinated delivery across functions, drawing on a scientific foundation that includes a PhD in Neurosciences and Neuropharmacology. Based in Paris, France, Claire aligns scientific insight with operational execution to support successful trial outcomes., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Claire%20Delaville.jpg',altText='Claire Delaville',fileId=214838927033}, lastname=Delaville, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285678112, hs_is_edited=false, hs_deleted_at=0, name=Claire, job=Senior Project Manager, slug=claire-delaville, hs_updated_by_user_id=26433386}})
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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1781285742914, description=Rui F. Duarte‑Lopes is a senior biostatistics leader with over 31 years of international experience across biopharmaceutical, biotechnology, and CRO sectors. He provides strategic statistical oversight, ensuring rigorous, high‑quality, and decision‑focused delivery aligned with sponsor and regulatory expectations. He has more than 12 years of CRO experience supporting Phase I–IV clinical trials and has held roles including Lead Statistician, Project Lead, and Senior Manager. His therapeutic experience includes oncology and autoimmune diseases, notably lupus erythematosus, Crohn's disease and rheumatoid arthritis. Specializing in oncology over the past six years, Rui focuses on advanced solid tumors and early‑phase studies, contributing to study design, interim analyses, and data‑driven decision frameworks., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rui%20F%20Duarte-Lopes.jpg',altText='Rui F Duarte-Lopes',fileId=213695319705}, lastname=Duarte-Lopes, hs_initial_published_at=1779886328878, hs_created_by_user_id=26433386, hs_created_at=1779886165792, hs_is_edited=false, hs_deleted_at=0, name=Rui F, job=Senior Manager, Biostatistics, slug=rui-f-duarte-lopes, hs_updated_by_user_id=26433386}, second={}, third={}})
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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1781285742914, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, PhD, hs_initial_published_at=1775839468505, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, position=Vice President, IVD Regulatory Consulting, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=26433386}, second={hs_id=164426546714, hs_child_table_id=0, hs_updated_at=1778171432595, hs_published_at=1781285742914, description=Angélique Heckmann, PhD is a people‑driven leader who combines scientific expertise and business acumen with a strong foundation in human values. With a background in therapeutic drug development and an MBA‑shaped strategic mindset, she focuses on building meaningful, long‑term relationships with teams, partners, and clients. By bridging science and strategy, she supports informed decision‑making, fosters collaboration, and helps translate innovation into real‑world impact—always guided by a shared purpose: advancing solutions that ultimately improve patients’ lives, avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/angelique-1.png',altText='angelique-1',fileId=194126030110}, lastname=Heckmann, PhD, hs_initial_published_at=1713174153602, hs_created_by_user_id=62155952, hs_created_at=1713172107894, hs_is_edited=false, hs_deleted_at=0, name=Angelique, job=Regional Vice President, Translational Business Solutions, slug=angelique-heckmann, hs_updated_by_user_id=26433386}, third={}})
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