• What Europe’s New Privacy Regulations Means For US Trials

    Clinical Informatics News | In less than eight months, The European Union’s General Data Protection Regulation goes into effect. The GDPR applies to all types of data, but it will have a special impact on clinical trials, even ones run by US companies.

    Oct 24, 2017

  • Amazon Is About To Disrupt The Drug Industry, But Not The Way Most Think

    Forbes |  It's now a foregone conclusion that Amazon.com will enter the healthcare sector, but it likely won't be in the manner the financial markets and healthcare industry are anticipating.

    Oct 20, 2017

  • ICH E6 R2: Talking Big Pharma’s Response To The Addendum

    Clinical Informatics News Contributed Commentary | To better understand the impact of ICH E6 R2 and the perception of the new guidance by pharmaceutical companies, Tufts, CluePoints, and PricewaterhouseCoopers (PwC) organized an industry roundtable, which sought to highlight the main aspects of the guidelines, how organizations are responding, and the challenges they now face in achieving a common level of understanding across their businesses.

    Oct 20, 2017

  • FDA Chooses Box for Cloud Content Management

    Clinical Informatics News Brief  The U.S. Food and Drug Administration (FDA) has reportedly selected Box’s cloud content management platform to modernize its technical infrastructure and drive new ways to work in the cloud.

    Oct 18, 2017

  • Clinical Informatics News Welcomes 2018 Best Practices Entries

    Clinical Informatics News | Clinical Informatics News is accepting entries to the 2018 Clinical Informatics News Best Practices competition.

    Oct 18, 2017

  • It’s About Time: Doing Things Right vs. Doing The Right Thing

    Clinical Informatics News | It’s About Time | Erica Heath, IRB Historian and Guru, wants to think long and hard about whether the clinical research enterprise should be doing things the right way — the culture of compliance — or going to the next step to doing the right things — the culture of conscience.

    Oct 17, 2017

  • Patient Engagement In Device Trials

    RAPS |  Last week, the US Food and Drug Administration's Patient Engagement Advisory Committee met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

    Oct 16, 2017

  • After 5 Years And 2 Clinical Trials, Patient #1 Stops Cancer Treatment

    Philly.com |  T.J. Sharpe, who shared his fight with Stage 4 Melanoma in the "Patient #1" blog, has recently decided to stop taking Merck's anti-PD-1 drug for treatment.

    Oct 16, 2017

  • Elsevier Donates Unified Data Model To The Pistoia Alliance

    Clinical Informatics News Brief | Elsevier has announced it is donating its Unified Data Model to The Pistoia Alliance. It will now be developed and extended under the stewardship of The Pistoia Alliance, with the ultimate aim of publishing an open and freely available format for the storage and exchange of drug discovery data.

    Oct 13, 2017

  • FDA Vote Sets Stage For Gene Therapy’s Future

    MIT Technology Review |  A first-of-its-kind medical treatment that replaces a mutated gene with a correct copy could soon be available in the U.S.

    Oct 12, 2017

  • Clinical Surveys Shed Light On The State Of Clinical Trial Data And Recruitment

    Clinical Informatics News | Several clinical surveys have been released recently, all illuminating the clinical trial industry, especially as it applies to trial data. Experts ranging from CROs to sponsors, as well as voices from the general public, gave their insight into the problems and challenges facing the clinical trial field.

    Oct 11, 2017

  • 3D Facial Recognition Gives Healthcare Data A New Look

    Clinical Informatics News Contributed Commentary | 3D facial recognition has potential to become the standard for authenticating users on mobile devices, allowing all players in the healthcare ecosystem to breathe easier when it comes to collecting and managing sensitive data or even identify patients.

    Oct 6, 2017

  • Scott Gottlieb Rocketed To The Top Of FDA. He May Keep Rising

    STAT |  The FDA commissioner has quickly won over some skeptics and is now seen as a front-runner to succeed his old boss, Tom Price, as health secretary.

    Oct 4, 2017