Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Introduction to medical diagnostics and research laboratories/Central and contract research lab

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1.5 Central and contract research lab

Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)[1][2]:

  • clinical studies
  • bioequivalence studies
  • study design and management
  • high-volume specimen testing
  • custom assay development
  • test kit development and supply

Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often referred to as "central laboratories," which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.[1][3] These central labs may also be contracted out to provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."[3] Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.[4][5]

1.5.1 Medical and other research in academia

Medical research also occurs in academia, and they need suitably equipped and staffed laboratories for conducting studies. As such, universities may host their own central or core laboratory for both in-house[6] and contract research services.[7]

Clinical studies and trials aside, other types of academic research may require laboratory services as well. Take for example the archaeology laboratory, which is responsible for cleaning, analyzing, and identifying artifacts and remains from various sites either as part of a greater research effort or as a contract laboratory service.[8][9] Research in information technology and communication also occurs in (dry) laboratories; examples include the privately owned Nokia Bell Laboratory[10] and the university-affiliated University of New Hampshire InterOperability Laboratory.[11]

References

  1. ↑ 1.0 1.1 "Definition of Central Laboratory". FDA Good Clinical Practice (GCP) Q&A. Model Agreements & Guidelines International. 19 April 2004. https://www.magiworld.org/FdaGcpRecords?Pkey=1134. Retrieved 18 November 2021. 
  2. ↑ Minor, L.K., ed. (2006). "Handbook of Assay Development in Drug Discovery". CRC Press. pp. 488. ISBN 9781420015706. https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover. 
  3. ↑ 3.0 3.1 Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. (6 May 2013). "Selecting a Central Laboratory". Contract Pharma. Rodman Media, Inc. https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/. Retrieved 18 November 2021. 
  4. ↑ "Global Network and Core Services". Labcorp Drug Development. https://drugdevelopment.labcorp.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html. Retrieved 18 November 2021. 
  5. ↑ "Central Lab Services". ACM Global Laboratories. https://www.acmgloballab.com/central-lab-services. Retrieved 18 November 2021. 
  6. ↑ "Core Laboratory for Clinical Studies (CLCS)". Office of the Vice Chancellor for Research. Washington University in St. Louis. https://research.wustl.edu/core-facilities/core-laboratory-clinical-studies/. Retrieved 18 November 2021. 
  7. ↑ "Clinical Trials Central Laboratory Services". University of Rochester Medical Center. https://www.urmc.rochester.edu/pathology-labs/central.aspx. Retrieved 18 November 2021. 
  8. ↑ "Archeology Laboratory". Augustana University. https://www.augie.edu/academics/academic-offices-and-centers/archeology-laboratory. Retrieved 18 November 2021. 
  9. ↑ "Lab - Archaeology Lab". Saint Louis University. https://www.slu.edu/arts-and-sciences/sociology-anthropology/labs.php. Retrieved 18 November 2021. 
  10. ↑ "History". Nokia Group. https://www.bell-labs.com/about/history/. Retrieved 18 November 2021. 
  11. ↑ "UNH-IOL FAQ". University of New Hampshire InterOperability Laboratory. https://www.iol.unh.edu/about/faq. Retrieved 18 November 2021. 
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