Data Standards Featured Articles

  1. J&J Takes The Lead In Clinical Data Transparency 8/10/2016

    It’s a problem that clinical researchers have dealt with for years. A researcher has an idea for a study. They identify an existing data set, produced by other researchers, which would be ideal for that particular study. Although that data is not currently being used, the researcher is not able to access and use the clinical trial data because it is not being shared. This is a situation that Johnson & Johnson (J&J) is hoping to change.

  2. Survey: Do Spreadsheets Still Hamper Clinical Trial Speed & Quality? 8/8/2016

    Clinical trial operations is fraught with many hurdles, including quality, cost, and timeliness. To successfully bring new medicines to market, operations managers have to successfully overcome these challenges. Application software provider Comprehend recently produced a “Clinical Operations Benchmark Report,” in which it surveyed executives at leading life science companies. The goal was to determine how companies can speed up trials and more quickly get to quality results across a portfolio of products.

  3. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016 7/8/2016

    Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.

  4. GSK's Bold Move Into Uncharted mHealth Waters 7/6/2016

    While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.

  5. eSource Implementation: Where Are We Now And Where Are We Going? 5/25/2016

    Over the last several years, life science firms have cautiously moved into the eSource arena. While companies look forward to attaining the benefits of eSource, they also have concerns over potential glitches, the impact on study teams, and regulatory issues. 

  6. Clinical News Roundup: Industry Seeks FDA Guidance On mHealth Technologies 5/13/2016

    Clinical Leader news roundup for the week of May 8, 2016, with articles on FDA guidance regarding mHealth technologies, Bitcoin improving transparency in trials, software to change the future of drug discovery, the growing use of wearables and social media in trials, and more.

  7. FDA Panel Decision On Eteplirsen: Disappointing But A Big Step Forward 5/5/2016

    A recent FDA advisory committee hearing on the Duchenne muscular dystrophy drug eteplirsen resulted in a recommendation against approval. Pat Furlong of the advocacy group Parent Project Muscular Dystrophy was disappointed in the decision, but also sees it as a big step forward for patients and caregivers.

  8. 5 Key Trends Driving Clinical Trial Innovation 5/3/2016

    With the rise in emerging technologies and advancements, the pharmaceutical and life sciences industry is rapidly going through transformation, where organizations are dependent on successful drug or pharmaceutical-related launches to drive profitability and growth.

  9. Can Digitizing Clinical Trials Help Reverse Eroom's Law? 4/28/2016

    Eroom’s Law models the decline in R&D efficiency of traditional pharmaceutical therapies.  Basically, it explains that even with the tremendous and continued advancements in technology—processing power, storage, and bandwidth capability (Eroom is Moore spelled backwards, as in Moore’s Law)—the R&D cost to bring a new drug to market is still increasing linearly.

  10. Speeding Research With Data Mining Expertise 4/26/2016

    According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.