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: Case Study: Nectin 4 Biomarker Testing for Oncology Clinical Programs Case Study: Nectin 4 Biomarker Testing for Oncology Clinical Programs

Translational Research

Case Study: Nectin 4 Biomarker Testing for Oncology Clinical Programs

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1788379322226, description=Christie Bongel is a scientist by training, but her true passion lies in leadership, particularly in building leaders and shaping high-performing, trust-based cultures. She believes that many talented bench scientists are promoted into management roles without formal leadership development and is committed to helping close that gap. While culture and people development may not always appear on a balance sheet, she views them as essential drivers of long-term organizational success. As a leadership-focused operations executive, Christie leads laboratory operations and strategy within a global network, partnering with pharmaceutical and biotechnology organizations to navigate complex oncology challenges. Her work spans translational oncology, clinical trial strategy, and laboratory execution, with a focus on translating scientific and operational complexity into clear, actionable strategies that drive meaningful outcomes., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1781614819314.png',altText='Christie Bongel',fileId=219203862915}, lastname=Bongel, hs_initial_published_at=1786473638412, hs_created_by_user_id=65712240, hs_created_at=1786473568408, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director, slug=christie-bongel, hs_updated_by_user_id=65712240}, second={}, third={}})
  • Christie Bongel avatar

    Christie Bongel
Discover
Read: Has the rest of the world finally caught up with Latin America? Has the rest of the world finally caught up with Latin America?

Clinical Trials

Has the rest of the world finally caught up with Latin America?

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=220405672474, hs_child_table_id=0, hs_updated_at=1788379304461, hs_published_at=1788379322226, description=Andrés Bayona, MD, MBA, is a tenured physician and healthcare executive with over 30 years of experience spanning clinical practice, healthcare management, and global clinical research operations. He holds a specialization in Internal Medicine, as well as advanced degrees in Health Services Management and an MBA. In his role as VP, Clinical Operations, his many years in CRO and global Pharma roles and deep connections within the Latin American healthcare industry make him uniquely qualified to guide our growth strategy in Latin America., avatar=Image{width=240,height=360,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Bayona_Andres_1445.jpg',altText='Bayona_Andres_1445',fileId=220973350833}, lastname=Bayona, hs_initial_published_at=1787769344448, hs_created_by_user_id=65712240, hs_created_at=1787769297292, hs_is_edited=false, hs_deleted_at=0, name=Andrés, job=Vice President, Clinical Operations, slug=andres-bayona, hs_updated_by_user_id=65712240}, second={}, third={}})
  • Andrés Bayona avatar

    Andrés Bayona
Discover
Read: Case Study: Rapid Execution of Assay Validation Rescued Global Study Case Study: Rapid Execution of Assay Validation Rescued Global Study

Translational Research - Assays

Case Study: Rapid Execution of Assay Validation Rescued Global Study

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=219184495938, hs_child_table_id=0, hs_updated_at=1786473626295, hs_published_at=1788379322226, description=Christie Bongel is a scientist by training, but her true passion lies in leadership, particularly in building leaders and shaping high-performing, trust-based cultures. She believes that many talented bench scientists are promoted into management roles without formal leadership development and is committed to helping close that gap. While culture and people development may not always appear on a balance sheet, she views them as essential drivers of long-term organizational success. As a leadership-focused operations executive, Christie leads laboratory operations and strategy within a global network, partnering with pharmaceutical and biotechnology organizations to navigate complex oncology challenges. Her work spans translational oncology, clinical trial strategy, and laboratory execution, with a focus on translating scientific and operational complexity into clear, actionable strategies that drive meaningful outcomes., avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/1781614819314.png',altText='Christie Bongel',fileId=219203862915}, lastname=Bongel, hs_initial_published_at=1786473638412, hs_created_by_user_id=65712240, hs_created_at=1786473568408, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director, slug=christie-bongel, hs_updated_by_user_id=65712240}, second={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1765824406763, hs_published_at=1788379322226, 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=65712240}, third={}})
  • Christie B. avatar

    Christie B.
  • Kennon D. avatar

    Kennon D.
Discover
Loading...