Regulatory Affairs Editorial

  1. Clinical News Roundup: GSK Uses Apple ResearchKit For Clinical Research
    7/22/2016

    Clinical news roundup for the week of July 18, 2016 featuring GSK's use of Apple ResearchKit, guidance on first-in-human clinical trials, clinical research transparency in India, nudging patients into clinical trials, and more.

  2. Are Your Clinical Trials Prepared For The Coming mHealth Tsunami?
    7/18/2016

    Excitement around mHealth technologies has been building for years. While initial apprehension kept many companies from jumping into the space, sensors are finally starting to make it onto patients. In this Q&A, Glen de Vries, president of Medidata Solutions, discusses progress the industry has made, concerns that remain, and what the future holds for mobile and wearable technologies.  

  3. Clinical News Roundup: Should You Be Concerned About For-Profit Review Boards?
    7/8/2016

    Clinical News Roundup for the week of July 4, 2016 featuring for-profit institutional review boards, inefficiencies in clinical trials, smarter approaches to oncology trial design, clinical trial logistics, and integration between ClinicalTrials.gov and Drugs@FDA.

  4. 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.

  5. 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.

  6. TMF Survey: Major Changes To Clinical Operations
    7/5/2016

    Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.

  7. Iroko Uses Event Monitoring System To Power Phase 3 Trial Of VIVLODEX
    6/13/2016

    In a recently completed Phase 3 trial, efficacy was demonstrated in patients with osteoarthritis pain who were treated with VIVLODEX, a low-dose SoluMatrix NSAID product. The Medication Event Monitoring System (MEMS) was used in the study to accurately track when patients required additional pain-relieving medication and to show that patients using VIVLODEX required less rescue pain medication.

  8. Clinical News Roundup: What If You Set Up A Clinical Trial & Nobody Signs Up?
    6/10/2016

    Clinical News Roundup for the week of June 6, 2016 featuring new trial recruitment tools, breast cancer innovations, FDA guidelines on EHR data in trials, adaptive trials for Alzheimer’s treatments, and the NIH abandons clinical research centers.

  9. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For May 2016
    6/5/2016

    Below are my top three articles downloaded on Clinical Leader for the month of May 2016. In case you missed them, please take this opportunity to see what everyone else was learning about Merck’s efforts to be a sponsor of choice, FDAs decision on Eteplirsen, and BMS’ success in clinical trials for Opdivo. 

  10. ASCO To Take A Closer Look At Patient-Reported Outcomes In Clinical Trials And Cancer Care
    6/2/2016

    While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.