• FDA, CluePoints Sign CRADA

    Clinical Informatics News | Last month CluePoints and FDA signed a CRADA, Cooperative Research and Development Agreement, to enhance data integrity in clinical trial submissions to the FDA using CluePoints software.

    Nov 9, 2016

  • FDA to study how promotional tweets for drugs should convey side effects

    STAT |  Drug makers and their marketing partners argue the FDA social media policies have failed to keep up with technology.

    Nov 9, 2016

  • As Election Storm Gathered, Arrowhead Drops Word About A Clinical Hold

    ENDPOINTS NEWS |  As everyone's attention was being commanded by the big presidential vote Tuesday night, Arrowhead Pharmaceuticals chose to put out word that its lead program has been put on hold by the FDA.

    Nov 9, 2016

  • Building A Culture Of Innovation In Healthcare

    Forbes |  Innovation in healthcare is notoriously tricky, but the Children's Hospital of Philadelphia are one organization that have got it nailed. CHOP are attempting to continue a track record of success with the creation of a new post of Vice President for Entrepreneurship & Innovation last year.

    Nov 8, 2016

  • FDA Releases Recommendations for Handling Race & Ethnicity in Clinical Trials

    Clinical Informatics News | The FDA recently released a guidance with the purpose of offering suggestions to researchers conducting clinical trials on how to handle issues as they pertain to race and ethnicity, especially a kind of standardization for collecting and reporting race and ethnicity data.

    Nov 8, 2016

  • FDA Officials: There Was “No Scientific Basis” For Duchenne Drug OK As Sarepta Complained Of “Dire Financial” Condition

    Endpoints News |  Two senior FDA officials mounted a vehement assault on Janet Woodcock's decision to push through an approval of Sarepta's Duchenne muscular dystrophy drug Exondys 51. New documents posted by the FDA, including a round of memos on the issue in September, warned FDA Commissioner Robert Califf that he was allowing an approval even though Woodcock had not considered all the analysis they had done to underscore the company's weak case, adding that there was no scientific basis to conclude that the drug was reasonably likely to benefit patients.

    Nov 4, 2016

  • What clinical trial results? Now you can see who isnt sharing their findings

    STAT |  A tracker was launched by a group of researchers and medical journals that has been pushing the pharma industry to do a better job of disclosing trial data.

    Nov 3, 2016

  • Why The Approach To Drug Pricing Has To Change Now

    Forbes |  As an industry, we must shift to a model that focuses on value and outcomes delivered, both to patients and to health systems.

    Nov 2, 2016

  • Litmus Health Seeks Alternative In Data Gathering For Clinical Trials

    Clinical Informatics News | Litmus Health recently launched into public beta at the University of Chicago. The data science platform has ambitions to make “the entire world will be one big clinical trial.”

    Nov 2, 2016

  • Cures Bill in Jeopardy Amid Drug Pricing Push

    The Hill |  A coalition of liberal groups has come out against passage of the measure this year, further putting its future in doubt.

    Nov 1, 2016

  • In Defense of Data Sharing But Done In The Right Way

    STAT |  If data are collected using standards that are compatible with each other, they will be more easily shared and provide the greatest return.

    Oct 31, 2016

  • Large Molecule Clinical Trials Taking Longer, Costing More

    Outsourcing-Pharma |  Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.

    Oct 31, 2016

  • 23andMe Reaches Enrollment Goal for Lupus Research

    23andMe |  23andMe and Pfizer are collaborating on a lupus trial. The two have enrolled 5,000 people with autoimmune disease, and hope to use genetic and survey data to learn more about the genetics of lupus.

    Oct 28, 2016

  • Comparing Drug And Medical Device Clinical Trials

    MassDevice |  Understanding the similarities and appreciating the differences of drug and medical device clinical trials is important. A well-organized, controlled clinical trial can save time and money. Additionally, the faster and more accurately a trial is performed, the faster the test article can be introduced to the market and begin helping the community.

    Oct 28, 2016

  • Veeva, Quanticate, The Forerunner Group, and more: News from October 2016

    Clinical Informatics News Briefs | New partnerships and products from BBK Worldwide, Emulate, Veeva, and more.

    Oct 28, 2016

  • Better Together: Unified Clinical Systems & Processes

    Clinical Informatics News | Typically, sharing information in the life sciences industry has proven more challenging primarily because of siloes in place between not only companies, but also functional areas within an organization. A unified clinical technology landscape can have a positive impact that ripples throughout the entire organization. 

    Oct 27, 2016

  • EpiPen Prescriptions Continue To Climb But Market Share Dropped

    STAT |  New data indicates prescriptions for the allergy emergency device are outpacing last year's figures. Overall, the number of prescriptions for EpiPen is up 14% through September, compared with the same period in 2015. In fact, there were 40% more prescriptions written in the first nine months of this year compared with 2013, even as the price for EpiPen was rising.

    Oct 25, 2016