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| [[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. | | [[File:Businessman working and writing notes in office (Unsplash).jpg|right|250px]]When considering a LIMS, its implementation must be thoroughly considered. It is easy to get carried away with the look and feel of the LIMS’ user interface (UI), its fancy features and its promises of pain-free workflows. However, there’s more to a LIMS than its functionality and appearance. You also want to consider how your future LIMS will be implemented. |
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| 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>:
| | You don’t have to look far to find lab professionals with horror stories of software implementations that were unnecessarily complicated, ultimately being abandoned due to cost overrides or the realization that the system would never meet the lab’s needs. The good news is that doesn’t have to be the case. A LIMS can be flexible and adaptable without requiring extensive configuration or customization, ready to go live if properly pre-optimized for your specific lab type. Coupled with clear vendor expertise and a full complement of vendor services and support, the implementation process can be short, within budget and meet all expectations successfully. This chapter explores how to achieve that. |
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| * Manage and track clinical trial kits.
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| * Manage multi-site logistics of specimens.
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| * Provide a reservation function for specimens.
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| * Manage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks and other required reporting.
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| * Provide special access privileges to sponsors, monitors and investigators.
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| * Support a wide variety of data transfer formats, including CDISC, ASCII, SAS and XML.
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| * Provide patient management, including demographics, consent forms, clinical notation and test results.
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| * Provide highly configurable "blinding" features for reports and the user interface.
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| * Track contracts, budgets and other financials.
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| * Develop exclusion rules and monitor exclusions.
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| * Support testing for a wide variety of disciplines.
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| * Provide study-specific monitoring and alerts.
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| * Provide granular cumulative reporting.
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| * Provide study-specific project portals that allow review of documents, data visualizations, training material and other study information.
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| ==References==
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| {{Reflist|colwidth=30em}}
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When considering a LIMS, its implementation must be thoroughly considered. It is easy to get carried away with the look and feel of the LIMS’ user interface (UI), its fancy features and its promises of pain-free workflows. However, there’s more to a LIMS than its functionality and appearance. You also want to consider how your future LIMS will be implemented.
You don’t have to look far to find lab professionals with horror stories of software implementations that were unnecessarily complicated, ultimately being abandoned due to cost overrides or the realization that the system would never meet the lab’s needs. The good news is that doesn’t have to be the case. A LIMS can be flexible and adaptable without requiring extensive configuration or customization, ready to go live if properly pre-optimized for your specific lab type. Coupled with clear vendor expertise and a full complement of vendor services and support, the implementation process can be short, within budget and meet all expectations successfully. This chapter explores how to achieve that.
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