Skip to content
Precision for Medicine
Contact Us
Press Release

FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

Read the release
biospecimen-data-management (1)

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

 

Explore

Related Services

  • Explore
    clinical-sample-kitting-services_card-thumbnail
    kitting

    Clinical Sample Kitting & Logistics

    Kit production, clinical site training, and full sample shipment logistics
    Explore
    kitting

    Clinical Sample Kitting & Logistics

    Kit production, clinical site training, and full sample shipment logistics
    Explore
  • Explore
    biostorage_card-thumbnail
    biospecimens

    Biostorage

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

    Explore
    biospecimens

    Biostorage

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

    Explore
  • Explore
    LabEportal

    Precision Lab e-Portal

    On-demand visibility into project, sample, kit, and shipment status provides 24/7 access to critical study data
    Explore

    Precision Lab e-Portal

    On-demand visibility into project, sample, kit, and shipment status provides 24/7 access to critical study data
    Explore

Explore the Precision blog

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

Explore our blog
Read: Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

Clinical Trials

Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780425957872, hs_published_at=1780425963343, 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 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={}})
  • Rui F Duarte-Lopes avatar

    Rui F Duarte-Lopes
Discover
Read: Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

Assays - Oncology

Case Study: Advancing IHC Assays from RUO to Clinical Trials and CDx

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1780425963343, 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=1780425963343, 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={}})
  • Kennon D. avatar

    Kennon D.
  • Angelique H. avatar

    Angelique H.
Discover
Read: China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches

Clinical Trials

China’s New Drug Regulatory Framework Positions the Country as a Global Hub for Innovative Medicine Launches

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=209983237513, hs_child_table_id=0, hs_updated_at=1774533604788, hs_published_at=1780425963343, description=Calvin Niu received his BD in pharmaceuticals from Lanzhou University. He has brought over 22 years of drug development and regulatory experience in pharmaceutical companies and CROs. Calvin’s regulatory expertise covers regulatory agency engagements and all types of regulatory submissions throughout product development and post market life cycles in oncology, immunology, ophthalmology, clinical nutrition, cardiovascular, gastroenterology, women’s health, CNS, rare disease, etc. , avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Calvin%20Niu.png',altText='Calvin Niu',fileId=209991702802}, lastname=Niu, hs_initial_published_at=1774533614867, hs_created_by_user_id=51739740, hs_created_at=1774531720533, hs_is_edited=false, hs_deleted_at=0, name=Calvin, job=Director, Regulatory Affairs, China, slug=calvin-niu, hs_updated_by_user_id=26433386}, second={}, third={}})
  • Calvin Niu avatar

    Calvin Niu
Discover
Loading...