Clinical Operations Featured Articles

  1. Can A New Outsourcing Approach Improve Clinical Trials?
    4/25/2017

    For companies wanting to outsource their trials but also harbor concerns over CRO size and staffing, is there a solution? One group thinks they have come up with the answer. Four companies have come together to form a consortium designed to provide pharma with a dedicated team of trial experts focused on making studies more efficient and cost effective. Current members of the alliance include FMD K&L, inSeption Group, Pyxa Solutions, and OneSource Regulatory, with a plan to add more members in the future.

  2. Proposed Tax Change Would Impact Clinical Research
    4/11/2017

    Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.

  3. AstraZeneca Strives For Greater Trial Transparency
    3/22/2017

    In February 2017, trial transparency provider TrialScope announced the launch of its Trial Results Summaries Portal that was developed in partnership with AstraZeneca. The Portal is a publicly accessible website where clinical trial sponsors can inform and educate trial participants and the general public about trial results in a non-promotional and non-biased venue.

  4. Open Source Data: Fact Or Fiction
    3/3/2017

    At the recent Data & Technology in Clinical Trials conference, I had the pleasure of listening to Aneesh Chopra speak. Chopra is the president of NavHealth and formerly served as assistant to President Barack Obama and Chief Technology Officer of the United States. His speech was electrifying, dynamic, and set the room abuzz.

  5. Clinical News Roundup: Women Significantly Benefit From OB/GYN Trials
    3/3/2017

    Clinical news roundup for the week of February 26 with information on women and OB/GYN trials, Sanofi partnering with Science 37, benefit explanations tied to increased recruitment, digital tools, and patient recruitment in rare disease trials.

  6. Are You Conducting Proper CRO Oversight?
    3/2/2017

    Are my CROs doing what I hired them to do? That is a question you may have asked yourself many times. Even if you have conducted a thorough CRO search and selected the one that best meets your needs, there is no guarantee it is performing the tasks most important to your clinical trial.

  7. GSK Uses Apple ResearchKit In Rheumatoid Study
    2/21/2017

    As the chief medical officer at GSK, Murray Stewart spends most of his time focused on patients. A recent PARADE (Patient Rheumatoid Arthritis Data from the Real World) study, launched last year, was the first time GSK attempted to use Apple ResearchKit in a clinical study. Within 48 hours, the company had over 200 downloads, and was hopeful they would not just receive data from patients, but insightful information.

  8. Clinical News Roundup: CTTI Issues Recommendations For Pediatric Trials
    2/17/2017

    Clinical news roundup for the week of February 12, 2017 featuring information on new CTTI recommendations, China’s trial application backlog, adaptive trial design adoption, growth in the mHealth market, and Merck’s Patient-Centered Cancer Care Access.

  9. The Science Of M&A: Making The Most Of Your Financial Resources
    2/16/2017

    As CEO for France-based biotech Onxeo, CEO Judith Greciet is always looking for new opportunities to bring complementary products on board to expand her company’s pipeline. Onxeo currently has three compounds in clinical development, with one at the end of its Phase 3 trial. “External development is a key path in our strategy to grow the company,” says Greciet. “Whether you refer to this as an acquisition or inlicensing, we knew we would require additional, innovative assets to widen our pipeline and increase the value of the company.”

  10. Paratek Successfully Tackles Patient Challenges in Phase 3 Trial
    2/8/2017

    Paratek bills itself as a pharmaceutical company developing innovative medicines based on tetracycline chemistry. In this Q&A, Dr. Evan Loh, president and COO for Paratek, discusses some of the clinical challenges faced when enrolling patients for the ongoing Phase 3 studies. In addition, he notes how completing these studies will position the company for a new drug application as early as the first half of 2018.