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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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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1765824414256, 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=26433386}, second={hs_id=200435431440, hs_child_table_id=0, hs_updated_at=1763745269993, hs_published_at=1765824414256, avatar=Image{width=636,height=476,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/AQ_GlobalAccess_AlexGrosvenor-3.jpg',altText='AQ_GlobalAccess_AlexGrosvenor-3',fileId=182031301743}, lastname=Grosvenor, hs_initial_published_at=1763745278294, hs_created_by_user_id=26433386, hs_created_at=1763745229272, hs_is_edited=false, hs_deleted_at=0, name=Alex, job=Alex Grosvenor is a Senior Vice President and Managing Director at Precision AQ. Based in London, Alex leads the International Pricing & Market Access Strategy team, which he established in September 2015. Over the past decade, he has built this team into a successful, thriving practice, with a reputation for delivering high-quality work and excellent recommendation for its clients. Alex brings more than 20 years’ consulting experience in the biopharmaceutical industry, over 15 of these in pricing & market access.He specialises in complex pricing strategies, including cross-indication strategy, launch-sequencing and international price referencing. He has worked across multiple therapy areas, including oncology, immunology, cardiovascular, orphan indications and cell & gene therapies., slug=alex-grosvenor, hs_updated_by_user_id=26433386}, third={}})
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