Data Standards Featured Articles

  1. Pharma “Not Prepared” For New EU Data Protection Regulation 8/23/2017

    Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.

  2. Breakthrough Therapy Designation Helps Genentech Navigate Difficult Trials 4/17/2017

    FDA started the Breakthrough Therapy Designation program in 2012. Since then, Genentech has garnered 15 designations, more than any other company. Jeffrey Siegel has been an instrumental component of that success. Siegel is Genentech’s senior group medical director and spent 14 years with FDA prior to joining the company. He has spent most of his career in pharma developing products to address the unmet medical needs of patients. 

  3. What Will Clinical Research Certification Mean To Pharma? 10/18/2016

    The National Board of Medical Examiners (NBME) is a not-for-profit organization that has been around for over 100 years. Its primary mission is assessing the qualifications of healthcare professionals. More recently, the group has been looking into developing an assessment that would be helpful to clinical researchers.

  4. TransCelerate Seeks To Improve Clinical Trial Quality 10/12/2016

    TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.

  5. 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.

  6. Clinical News Roundup: HHS To Provide More Info To Patients 9/23/2016

    Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.

  7. 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.

  8. How To Incorporate Digital Technologies In A Clinical Protocol 9/9/2016

    Mobile and wearable technologies are making their way into clinical trials, helping to produce better data and engage patients in their health and treatments. But incorporating these devices also presents additional risks. What can companies do to overcome barriers and incorporate these devices into clinical trial protocols? In this Q&A article, Dmitri Talantov, M.D., R&D Operations Innovation Medical Leader, Janssen Research & Development, LLC shares his insights.

  9. 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.

  10. 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?