biorasi Blogs
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Considerations For Working With Research-Naive vs. Experienced Sites
5/1/2019
Some sites have a lot of experience, and those are generally sought after, but they can be busy running other trials and may not prioritize yours. It may be beneficial to include less experienced sites in order to have better chances of enrolling. But of course, there are some necessary considerations when turning to these sites.
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Why Aren’t There Any FDA-Approved Drugs To Treat NASH?
5/1/2019
No drugs have been approved by the FDA to treat NAFLD or NASH. Fortunately, there are some promising studies being conducted right now with numerous companies invested in the race. Why is there such a large gap to fill in this indication?
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You’re Holding Your Eye Drops Wrong – What Makes Ophthalmology Trials So Challenging?
4/30/2019
Recently, one of our resident experts in ophthalmology, Ignacio Handal, gave a training for some of our current studies with a focus on which pitfalls to avoid specifically in ophthalmology trials. He dished out many fun facts and eye-opening insights.
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A More Complete Scope For Advances in Women’s Health
4/30/2019
The field of medicine pertaining to women’s health is rapidly growing to include the study of both specific conditions that only manifest in women and also maintenance of well-being and quality of life during the unique but normal life cycles experienced by women. Fortunately, we are beginning to understand the implications of women-specific needs on mental and emotional health, and new devices are being designed to cater to these needs.
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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.
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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?
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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.
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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.
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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.
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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.