EDC/Data Management Featured Articles

  1. Clinical News Roundup: Almac And inVentiv Health Partner On IRT
    12/9/2016

    Clinical news roundup for the week of December 4, 2016 with information on Almac partnering with inVentiv on IRT, ERT acquiring Exco In Touch, and the 21st Century Cures bill passing the Senate and moving on to the White House.

  2. SCRS: Site/Sponsor Relationship Needs Improvement
    10/28/2016

    At the 2016 SCRS (Society for Clinical Research Sites) Global Site Summit, Christine Pierre, president of SCRS, shared the results of a survey conducted of site professionals from around the world. The survey is conducted every year, just prior to the summit, to gauge the opinion of site professionals on various issues and trends. If the results are any indication, there is still room for improvement in sponsor/site relationships.

  3. Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?
    9/30/2016

    Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.

  4. Podcast: Pfizer Transforms Clinical Trials for Parkinson’s Patients
    9/26/2016

    When Pfizer partnered with IBM to try and transform how clinical trials for Parkinson’s patients are conducted, the company had a vision that was both revolutionary and futuristic. The plan was to take a group of patients, place them in a specially designed home to live for a period of time, and use sensor technology to monitor their capabilities.

  5. SCDM Best Practices Now Available To Nonmembers
    9/13/2016

    Data managers are critical to the clinical research process. It’s the data they collect which will ultimately determine whether a new drug gains FDA approval. Recognizing that, the Society for Clinical Data Management (SCDM) was established to work with the teams creating clinical trials, writing the protocols, and identifying the information that needs to be captured. Over the years, the information gathered by SCDM members has been incorporated into a guide book of Good Clinical Data Management Practices, which SCDM is now making available to nonmembers as well as association members.

  6. Clinical News Roundup: Bioclinica To Be Acquired By Cinven
    8/26/2016

    Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.

  7. Clinical News Roundup: Can Clinical Trials On Pets Help People?
    8/12/2016

    Clinical news roundup for the week of August 8, 2016 with articles on using pets in clinical trials, the Quintiles/DaVita alliance, the benefits and pitfalls of data sharing, and the Orphan Drug Act.

  8. How RBM Is Changing The Role Of Monitors
    8/11/2016

    Is risk-based monitoring (RBM) changing the role of monitors in clinical trials? In the latest issue of the Pharmaceutical Outsourcing Monitor, Michael Martorelli of Fairmount Partners takes a look at this issue, and features some interesting feedback from readers along with informative insights from Jim Kremidas of ACRP and Clara Heering of ICON. How is RBM changing the role of monitors and what do you need to know?

  9. 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.

  10. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For July 2016
    8/1/2016

    Below are my top three articles downloaded on Clinical Leader for the month of July 2016. In case you missed them, please take this opportunity to see what everyone else was learning about GSK’s bold moves into mHealth, the efforts of Duke and PCORI to transform clinical trials, and the coming mHealth tsunami.