biorasi Blogs

  1. The Power of Patient Registries - How To Collaborate With Patients To Enhance Orphan Drug Research
    6/11/2019

    Patient registries assist orphan drug development by giving manufacturers access to clinical, genetic, and biological data from a large patient population. Using registries, sponsors can better understand the disease, its history, and patients’ needs, all of which benefit clinical trial design and effectiveness.

  2. What To Look for When Selecting A Risk-Based Monitoring Partner
    5/22/2019

    There are no concrete instructions when it comes to RBM, and planning a successful RBM design can be challenging. Even so, we believe investing in an experienced partner to help you with RBM design is worthwhile. RBM can be an indispensable tool for your trial’s success. Following is an out of outline a criteria that could be helpful in finding the right RBM specialist.

  3. 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.

  4. 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.

  5. 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.

  6. Determining The "ROI" Of Clinical Trial Rescue Before It's Too Late
    5/8/2019

    The longer you addressing a faltering clinical trial, the greater the risk your trial progresses from faltering to failure. And the deeper a trial's problems, the more likely you'll have to ask for a substantial budget increase—another difficult conversation. Here are some tips to act quickly for the best ROI.

  7. 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.

  8. 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.

  9. 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.

  10. 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.