Pharma “Not Prepared” For New EU Data Protection Regulation
Pharma “Not Prepared” For New EU Data Protection Regulation

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.

  • TransCelerate Seeks To Improve Clinical Trial Quality
    TransCelerate Seeks To Improve Clinical Trial Quality

    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.

  • Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?
    Clinical News Roundup: Is 80 Percent Of China’s Clinical Data Fabricated?

    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.

  • Clinical News Roundup: HHS To Provide More Info To Patients
    Clinical News Roundup: HHS To Provide More Info To Patients

    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.

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  • What The Fitbit Is Helping Pharma Learn About Patients

    Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.

  • Electronic Informed Consent: Considerations For Implementation In Clinical Trials

    In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.

  • End-To-End Management Of Clinical Trials Data

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.

  • Electronic Source Record: Fulfilling The Promise Of EDC

    The much-heralded EDC revolution has reached a decisive point, to use an equally heralded term, a ‘tipping’ point. 58% of clinical trials started last year employed EDC systems.

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