Weekly Features

FDA, IBM partner on the secure exchange of clinical data

Monday, January 23, 2017

Secure storage and controlled access to sensitive patient data are critical aspects of the clinical trial process. Investigators may need to access huge data sets shared across national and international sites. The amount and sheer number of types of data is rapidly increasing as the use of mobile and wearable devices and the querying of genomic databases are incorporated into trial design.

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Clinerion enters an improved clinical trials market in Brazil

Monday, January 16, 2017

In mid-December, Clinerion, a patient recruitment company, made its entrance into the clinical trials market in Brazil. With a state-of-the-art patient recruitment system (PRS) that has a track record of rapid identification of eligible patients in other markets, Clinerion is poised to make a significant difference in Brazil.

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St. Jude cybersecurity vulnerabilities spark medical device hacking debate

Monday, January 16, 2017

A recent cybersecurity scandal involving St. Jude’s Merlin@home device sparked a renewed discussion within the medical device industry about the best way to address security flaws discovered by independent security experts, sometimes called “white hat” hackers. As medical devices become increasingly vulnerable to cyber attack, the industry has broadly accepted its new responsibility of continuously protecting approved devices from potential security breaches.

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GSK deal with Italian Medicines Agency highlights performance-based curative model

Monday, August 29, 2016

GlaxoSmithKline (GSK) has signed a pay-for-performance deal with the Italian Medicines Agency (AIFA) to boost usage of Strimvelis, the pharmaceutical company’s gene therapy treatment developed for ADA-SCID, a rare genetic disorder in children. The key to the contract, however, is that the drug must work. If treatment doesn’t provide a cure, GSK must return a portion of the funds paid by AIFA based on the terms of the agreement.

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