Difference between revisions of "User:Shawndouglas/sandbox/sublevel4"

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[[File:Colorado Department of Public Health and Environment.JPG|right|300px]]A public health laboratory is unlike the average clinical diagnostics laboratory as it must typically meet more stringent requirements. For example, they must adhere to not only CLIA (for labs in the United States), but also additional regulations laid out by the departments, agencies and other regulatory bodies of local, state and/or national governments. Additionally, the public health lab serves entire populations, not just individuals.<ref name="BeckerAnIntro10">{{cite book |url=https://books.google.com/books?id=6SDqL72zPRUC |title=Public Health Laboratories: Analysis, Operations, and Management |chapter=Chapter 1: An Introduction to Public Health Laboratories |author=Becker, S.; Perlman, E.J. |editor=Jenkins, W. |publisher=Jones & Bartlett Learning |pages=1–14 |year=2010 |isbn=0763771023}}</ref><ref name="BeckerPublic05">{{cite book |url=https://books.google.com/books?id=bFBPMcQe6ogC |title=Public Health Administration: Principles for Population-based Management |chapter=Chapter 27: Public Health Laboratory Administration |author=Becker, S.J.; Blank, E.C.; Martin, R.; Skeels, M. |editor=Novick, L.F.; Mays, G.P. |publisher=Jones & Bartlett Learning |pages=623–627 |year=2005 |isbn=0763740780}}</ref> As such, these differences require the public health LIMS to provide additional functionality to help public health labs meet their population-based mandates.
[[File:Clinical Trial Participant Receives Injection (34033294061).jpg|right|200px]]Medical research laboratories (e.g., central and contract labs) form the backbone of today's effective medical treatments, through the pathway of clinical trials. These clinical trials involve analytical testing and other activities across many domains, including pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.<ref name="CovanceClinical">{{cite web |url=https://drugdevelopment.labcorp.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html |title=Global Network and Core Services |publisher=Labcorp Drug Development |accessdate=09 March 2022}}</ref><ref name="ACMCentral">{{cite web |url=https://www.acmgloballab.com/central-lab-services |title=Central Lab Services |publisher=ACM Global Laboratories |accessdate=09 March 2022}}</ref> These activities require extra features beyond those found in a basic clinical diagnostics LIMS in order to effectively collect and use the clinical trial data in a secure and meaningful way.


In addition to the essential features of a standard LIMS, the public health lab will also be looking for a system that can (or allows users to)<ref name="APHLLab19">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf |format=PDF |title=Laboratory Information Systems Project Management: A Guidebook for International Implementations |author=Association of Public Health Laboratories |publisher=APHL |date=May 2019 |accessdate=18 November 2021}}</ref><ref name="LabWarePublic20">{{cite web |url=https://www.labware.com/industries/healthcare#publichealth |title=Public Health |publisher=LabWare, Inc |date=2021 |accessdate=18 November 2021}}</ref><ref name="OrchardPublic20">{{cite web |url=https://www.orchardsoft.com/solutions/public-health-labs/ |title=Public Health Laboratories |publisher=Orchard Software Corporation |date=2021 |accessdate=18 November 2021}}</ref><ref name="CommonCentsApollo20">{{cite web |url=https://www.apollolims.com/lab-expertise/public-health/ |title=ApolloLIMS for Public Health Labs |publisher=Common Cents Systems, Inc |date=2021 |accessdate=18 November 2021}}</ref>:
In addition to the essential features of a standard LIMS, the central and contract research lab conducting clinical trials will also be looking for a system that can (or allows users to)<ref name="EurofinsSupport20">{{cite web |url=https://www.eurofins.com/biopharma-services/central-lab-old/support-services/data-management/ |title=Supporting Services - Data management |publisher=Eurofins Scientific |date=2021 |accessdate=18 November 2021}}</ref><ref name="AbbotStarlimsClin20">{{cite web |url=https://www.starlims.com/us/en/industries/clinical-research |title=Starlims Clinical Research LIMS |publisher=Abbot |date=2021 |accessdate=18 November 2021}}</ref><ref name="LabWareClinical20">{{cite web |url=https://www.labware.com/industries/biobanking-clinical#clinical |title=Clinical Research |publisher=LabWare, Inc |date=2021 |accessdate=18 November 2021}}</ref><ref name="MedpaceClinTrak20">{{cite web |url=https://www.medpace.com/capabilities/technology/laboratory-information-management/ |title=ClinTrak Lab |publisher=Medpace, Inc |date=2021 |accessdate=18 November 2021}}</ref>:


* Provide specialty workflow for newborn screening.
* Manage and track clinical trial kits.
* Provide surge capacity for high-priority analyses.
* Manage multi-site logistics of specimens.
* Provide workflow and tools for managing microorganisms and toxins of elevated risk.
* Provide a reservation function for specimens.
* Support most medical test protocols and specimen types.
* Manage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks and other required reporting.
* Support ELISA, DNA extraction, sequencing and other molecular workflows.
* Provide special access privileges to sponsors, monitors and investigators.
* Support for a robust set of decision support rules for reflex testing.
* Support a wide variety of data transfer formats, including CDISC, ASCII, SAS and XML.
* Support the Centers for Disease Control and Prevention's PHIN Messaging System.
* Provide patient management, including demographics, consent forms, clinical notation and test results.
* Support other electronic data exchange standards for critical community partners.
* Provide highly configurable "blinding" features for reports and the user interface.
* Track contracts, budgets and other financials.
* Develop exclusion rules and monitor exclusions.
* Support testing for a wide variety of disciplines.
* Provide study-specific monitoring and alerts.
* Provide granular cumulative reporting.
* Provide study-specific project portals that allow review of documents, data visualizations, training material and other study information.


==References==
==References==
{{Reflist}}
{{Reflist|colwidth=30em}}

Revision as of 20:50, 9 March 2022

Clinical Trial Participant Receives Injection (34033294061).jpg

Medical research laboratories (e.g., central and contract labs) form the backbone of today's effective medical treatments, through the pathway of clinical trials. These clinical trials involve analytical testing and other activities across many domains, including pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.[1][2] These activities require extra features beyond those found in a basic clinical diagnostics LIMS in order to effectively collect and use the clinical trial data in a secure and meaningful way.

In addition to the essential features of a standard LIMS, the central and contract research lab conducting clinical trials will also be looking for a system that can (or allows users to)[3][4][5][6]:

  • Manage and track clinical trial kits.
  • Manage multi-site logistics of specimens.
  • Provide a reservation function for specimens.
  • Manage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks and other required reporting.
  • Provide special access privileges to sponsors, monitors and investigators.
  • Support a wide variety of data transfer formats, including CDISC, ASCII, SAS and XML.
  • Provide patient management, including demographics, consent forms, clinical notation and test results.
  • Provide highly configurable "blinding" features for reports and the user interface.
  • Track contracts, budgets and other financials.
  • Develop exclusion rules and monitor exclusions.
  • Support testing for a wide variety of disciplines.
  • Provide study-specific monitoring and alerts.
  • Provide granular cumulative reporting.
  • Provide study-specific project portals that allow review of documents, data visualizations, training material and other study information.

References

  1. ↑ "Global Network and Core Services". Labcorp Drug Development. https://drugdevelopment.labcorp.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html. Retrieved 09 March 2022. 
  2. ↑ "Central Lab Services". ACM Global Laboratories. https://www.acmgloballab.com/central-lab-services. Retrieved 09 March 2022. 
  3. ↑ "Supporting Services - Data management". Eurofins Scientific. 2021. https://www.eurofins.com/biopharma-services/central-lab-old/support-services/data-management/. Retrieved 18 November 2021. 
  4. ↑ "Starlims Clinical Research LIMS". Abbot. 2021. https://www.starlims.com/us/en/industries/clinical-research. Retrieved 18 November 2021. 
  5. ↑ "Clinical Research". LabWare, Inc. 2021. https://www.labware.com/industries/biobanking-clinical#clinical. Retrieved 18 November 2021. 
  6. ↑ "ClinTrak Lab". Medpace, Inc. 2021. https://www.medpace.com/capabilities/technology/laboratory-information-management/. Retrieved 18 November 2021. 
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