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Over the last decade, there has been an increase in the use of diagnostic tools at Investigator sites. Applications of hand held, portable and table top models have been published in the methods section of several large clinical trial reports. In some studies, encrypted versions of these diagnostic tools were employed to reduce bias. We have direct experience with the sourcing, development, training and application of these unique diagnostic tools.
Pharma News and Events:

April 22-24 2015


 
 
 
 











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Point of Care ACT
 
Point of Care ACT used to Evaluate the Pharmacodynamics, the safety and tolerability, and the pharmacokinetics of several Intravenous regimens of a factor Xa inhibitor, in comparison to intravenous unfractionated heparin in subjects undergoing non-urgent PCI
     
 
Point of Care Lactate
 
Point of Care lactate testing predicts mortality of severe sepsis in a predominantly HIV type 1-infected patient population in Uganda
     
 
Epilepsy Drug Study
 
Epilepsy Drug Study: Ambulatory EEG Application for Safety and Efficacy
     
 
Point of Care Hemoglobin Device
 
Point of Care Hemoglobin device used in a Multicenter Study of the Initiation of Four Dosing Regimens of ERYTHROPOIETIN or the Treatment of Anemia of Chronic Kidney Disease (CKD)
     
 
Low Molecular Weight Heparain
 
Point of Care Coagulation for standardized monitoring and dose adjustment during a clinical trial of a Low Molecular Weight Heparin
     
 
Pharmaceutical Trials Employing POCT
 
The following is a partial listing of clinical trials performed to establish efficacy of novel pharmaceuticals that have employed point-of-care testing (POCT) as an integral part of the protocol. The listed studies are peer reviewed publications of study results.
     
 
The Case for the Use of Point-of-Care Testing in Pharmaceutical Clinical Trials
 
Clinical trials that are designed to evaluate the efficacy of novel pharmaceuticals require a variety of diagnostic tests to be performed on all enrolled patients. This article examines and compares the central lab and point-of-care testing options.
     
 
Trends in Clinical Practices: Growth of POCT
 
Point-of-care testing (POCT) is an increasingly popular means of delivering test results traditionally obtained from a laboratory. When used appropriately, POCT can improve patient outcome by providing a faster diagnostic result and a shorter timeframe to therapeutic intervention.
     
 
Turn-Around Time Case Study
 
This study compares POCT to Central Lab with regards to turn-around time of results.
     
 
Hybrid Laboratory Testing
 
Combining the technology available in a central lab with POCT devices offers to clinical trial sponsors the opportunity to have tests performed at the investigator site, a pharmacy, a remote clinic or at home. The test or battery of tests run on the POCT device using a whole blood sample that does not need to be centrifuged or shipped offers not only cost savings but also enhanced trial data integrity, since approximately 2-3% of samples are lost in transit to the central lab and any number of samples may be compromised due to extremes in temperature or pressure encountered in transit.
     
 
Blinded Diagnostics INTRO
 
An Introduction to Blinded Diagnostics Services
     
 
Katrina, the Tsunami, and Point-of-Care Testing
 
We assessed how point-of-care testing (POCT), diagnostic testing at or near the site of patient care, can optimize diagnosis, triage, and patient monitoring during disasters. We surveyed 4 primary care units(PCUs) and 10 hospitals in provinces hit hardest by the tsunami in Thailand and 22 hospitals in Katrinaaffected areas. We assessed POCT, critical care testing, critical values notification, demographics, and disaster responses.
     
 
Bolstering Clinical Trials
 
eBook published on Fierce Markets (Aug. 26, 2013) entitled "Bolstering Clinical Trials"
     
 






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