biorasi Blogs

51. The Politics of Investigator-Initiated Trials 4/30/2019

    IITs present a way for post-marketing, real-world data to be added to a drug or device’s portfolio without the sponsor initiating the research. Everyone can agree on the fact that more research, and especially real world evidence, is helpful for advancing the field of medicine, but not everyone is always in favor of IITs. Following are problems and benefits of IITs.

52. The Tumultuous History Of Women's Involvement In Clinical Research 4/30/2019

    A 1977 FDA recommendation resulted in women being largely excluded from clinical research for the next few decades. And then the pendulum swung. In 1988 and in the years thereafter, many different initiatives began to advocate for the inclusion of women in clinical research. But have these initiatives changed anything?

53. Managing Alzheimer's Trials In A Diverse Global Environment 4/29/2019

    Multinational or not, study sites in a clinical trial must be standardized to follow the same protocol. Disparities and issues with standardization make it difficult to run successful, generalizable Alzheimer’s trials. Read on to learn about common disparities and faced in the Alzheimer trial space along with possible solutions.

54. Five New Tech Options To Use In Your Virtual Trial 4/29/2019

    At Biorasi, we have been wondering if it is really possible to design a trial to be completely virtual and what that would entail. Read more about some interesting technologies that could be put to use in a virtual, or maybe semi-virtual, trial.

55. How Are Adaptive Trial Designs Improving Efficiency In Clinical Research? 4/29/2019

    The ability to adapt is a valued attribute in today’s constantly changing world, and clinical trial designs are no exception. Adaptive trial designs can save sponsors significant time and money, but they need to be approached with caution and planning.

56. Reservations Held By Referring Physicians In Clinical Trials 4/29/2019

    Some physicians are reluctant to participate in clinical trials as a referring physician. This is a huge issue because a large portion of participants can come directly from a referring physician’s office. Christina Norris, VP of Clinical Operations at Benchworks and specialist in planning, developing and executing patient recruitment programs for clinical trials offers possible solutions for this problem.

57. Don't Let Summer Obstacles Catch You Off Guard 4/29/2019

    In research, anytime variation is introduced and unaccounted for, it can mask the true results of an intervention. The summer season can contribute to variation and can introduce other specific challenges to a clinical trial. Following are solutions that can be implemented during the planning stages of a study as well as creative solutions for rescuing a trial failing for seasonal reasons.

58. Cellular Therapy In Neurological Diseases 4/26/2019

    A look at the latest advances in this area as well as challenges that sponsors face when running cell therapy-based trials.

59. Patient Recruitment Solution: How To Ease Fear Of The Unknown In Clinical Trials. 4/26/2019

    Understand the role of a study navigator and how they help to ease patient worries and ups the odds they’ll enroll—and stay enrolled—in your study.

60. Advances In Non-Opioid Options For Post-Operative Pain Management 4/26/2019

    In line with FDA’s plans to address to opioid crisis, research groups, pharmaceutical and biotech companies, and medical device manufacturers have increased efforts to develop non-opioid treatments for acute and chronic pain. Read more to understand the scientific, project management, and public health hurdles with these new efforts and how to overcome them.