Leveraging Cloud-based EDC for Data Acquisition and Sharing

Jan 8, 2016

A primary challenge faced by clinical trial professionals around the world is the means by which data is collected and logged for their studies. There are three principle ways of recording this data: pen and paper, traditional computerised data capturing applications, and more recently, cloud-based electronic data capture (EDC). Glenn Keet, CEO of Clinovo, submits a technical article on cloud- based EDC. ...

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Healthware – Beyond Bracelets and Watches

Jan 8, 2016

Norman J. Holter, regarded as the “Father of mobile ECG monitoring”, developed the world’s first ambulatory cardiology monitor, and arguably, the world’s first wearable device, in 1954. The device weighed 85 pounds and had to be strapped to the patient like a bulky backpack. For the very first time, the patient’s cardiac wellbeing could be tested in his natural state, at any point during the day. No longer did the physician wait by the patient’s bedside to detect an arrhythmia, nor did the testing have to happen in a controlled clinical environment. Bhargav Rajan, senior research analyst at TechVision, concentrates ...

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High Quality, Fast Antibody Conjugates in Complete ELISA Kits

Jan 8, 2016

Every immunoassay exploits the ability of an antibody (referred to as a primary antibody) to bind selectively to a particular target antigen, which is usually presented in a complex fluid such as serum, blood or urine, or in a solid matrix such as a slice of tissue, a cell monolayer, a nitrocellulose blot or a plastic microplate. The antibody, in conjunction with a label that provides measurability, allows the quantity and/or distribution of the antigen to be determined. Amy Adams, Technical Support and Customer Service Supervisor at Innova Biosciences, with Professor Paul J. Davis, Founder/CSO and Julie Thompson, Research scientist ...

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The Use of Preclinical Models to Drive Immunotherapy Cancer Research and Combination Strategies

Jan 7, 2016

The ideal treatment for any disease is one that can cure it or prevent spreading with minimal impact on the patient’s quality of life. In the case of cancer, therapeutic agents were initially designed to kill rapidly dividing cells. Dr Jean Pierre Wery, President of Crown Bioscience, reflects on the use of preclinical models to drive immunotherapy cancer research and combination strategies highlighting syngenic mouse models for immunotherapy and radiotherapy, combination therapies and strategies. ...

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ISO IDMP Short Timelines and Limited Information: How Do You Solve the Challenges and Prioritise your Efforts? – Rune Berggendorf, NNIT

Jul 1, 2015

ISO IDMP has been around since 2012, when the standards were initially published, and since November 2012 the implementing regulation 520/2012 has been in place. Now, four years later, the deadline of July 1st, 2016, is closing in and information on how and what to implement is still scarce due to outstanding implementation guidelines from ISO, and hence no implementation guidelines from EMA. Rune Bergendorff from NNIT looks into the ISO IDMP short timelines and limited information, and then he answers the question, how do you solve the challenges and prioritise your efforts? ...

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