biorasi Blogs
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Can Big Data Rescue Clinical Trials
5/22/2019
Big data and data mining are being leveraged to improve drug development, with huge potential implications in identifying and correcting issues that arise during clinical trials. This article is a quick overview of what big data is and how we look at and define program failures and faltering trials.
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Not Enrolling Enough? How To Rescue Your Recruitment
5/8/2019
A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.
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Is Your Clinical Trial In Need Of A Rescue?
5/8/2019
Don’t assume your clinical trial will survive endless change orders, extended deadlines, cost overruns, and missed objectives. Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
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Is Gut Microbiome Behind Our Next Breakthrough Therapy?
5/6/2019
We’re now only beginning to understand how the microbiome influences our health and behavior and vice versa. As we learn more about its connection to a host of diseases and disorders, we expect to see specific bacterial molecules as potential druggable targets.
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When Virtual Trials Are Not The Answer
5/6/2019
When used successfully, the virtual clinical trial model promises to enroll more patients faster, improve patient retention, and reduce costs. For all their perceived advantages, a virtual model doesn’t suit all studies. Read some challenges of virtual trials as well as when they do and do not work.
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Dermatology Detectives: How The Right Principal Investigator Can Increase Patient Trust And Compliance
5/6/2019
When conducting complex dermatology clinical trials with difficult to treat, rare, or complicated skin conditions, the study’s success or failure can often hinge on the relationship between the PI and patients. Learn what to look for in a dermatology study investigator.
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How To Minimize Subjectivity In Dermatology – Part 1: Principal Investigators And Clinical Staff
5/3/2019
The success of any clinical trial depends on unbiased data. However, the subjective nature of many dermatology assessments makes unbiased data harder to come by. Inconsistent reports based on subjective findings can skew data, which may obscure the true effects of treatment. In-depth training of investigators and staff helps minimize subjectivity, but even traditional training can fall short. Here are a few solutions.
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Cosmeceuticals: How To Navigate The Legal And Regulatory Hurdles Of A Growing Market
5/3/2019
Laws and regulations differ greatly between drugs and cosmetics. Drugs must be submitted for FDA approval. Cosmetics are not. Product manufacturers should know what constitutes a legitimately clinically proven cosmeceutical, as well as what the FDA has to say about these cosmetic-drug hybrids.
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What Is The Skin Microbiome?
5/3/2019
The microbiome refers to the genetic material of all the microbes that live on and inside the human body. Using DNA sequencing, researchers are only beginning to uncover links between the microbiome and a host of diseases, including several types of cancer, autoimmune conditions, inflammatory bowel disease, and Crohn’s disease, among others.
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What Are The Advantages Of Virtual Trials?
5/2/2019
Cost-savings and patient-centricity are two forces that are combining to push the boundaries of what a clinical trial is and can be. One of the new solutions is the virtual trial, and it carries with it many advantages over a traditional trial. Read more about the advantages of virtual clinical trials.