• About
    • About Biorasi
      • Meet Biorasi

        Biorasi, founded in 2002, has partnered with global
        sponsors to enable FDA, EMA, and multi-venue
        approvals for numerous small molecules and
        biologics. Headquartered in Miami, Florida,
        Biorasi maintains office-based teams
        around the globe.

    • Our People
      • Cultivating The Future

        Biorasi hires the best – from industry and regulatory agency veterans to promising young talent on the rise. Biorasi’s leadership is made up of forward-looking visionaries with an unparalleled commitment to excellence in the services we provide to our sponsors and partners.
    • Our Board
      • Leading the Industry

        Our board is comprised of some of the most brilliant minds working in biopharma. Our directors and advisers help guide the company and act as a vital strategic asset both for Biorasi and our sponsors.
    • Careers
      • Careers

        We are looking to hire the best from inside and outside the industry. If you have an unparalleled commitment to excellence, a passion for making life better, and a drive for success, we’d like to talk to you.
  • Services
    • Study Rescue
      • Study Rescue


        Biorasi has a long track record of being able to
        right faltering programs. We have worked both
        as an integrated CRO, adding our strengths
        to a trial’s incumbent CRO, as well as a
        transition CRO, by assuming primary
        study management responsibility
        from the incumbent organization.

        Read how Biorasi can
        help rescue your trial

    • Project Management
      • Project Management

        We believe that only fundamentally sound project management can ensure trial success, and that only properly trained project managers, backed up by industry-leading processes, and innovative tools, can ensure sound project management.

    • Regulatory Services
      • Regulatory Services

        Regulatory affairs strategy is one of the biggest hurdles in running clinical trials. Increased trial complexity, regulation, and the need for multi-venue approval are driving this trend. Biorasi’s regulatory team has worked with regulatory agencies around the globe, including the most difficult venues.

    • Safety
      • Safety and Pharmacovigilance

        Biorasi’s best-in-class processes and technologies help our team identify safety trends and risks in sponsor studies quickly, and give us insight on how to resolve them without risking the trial. Fast detection, fast response, and fast resolution ensure our trials always stay on time.

    • Data Science/Biometrics
      • Data Science & Biometrics

        We make trial data an integral part of guiding trial success. Biorasi builds out standard data structures from the beginning and uses big data-style analytics to make your data immediately useful. This front-loaded approach saves sponsors time and money and minimizes risks.

    • Quality Assurance
      • Quality Assurance

        Biorasi is constantly evolving and improving, always under the guidance of quality first. Our quality team audits our internal functions as well as our sponsor studies to make sure that plans and SOPs are adhered too.

    • Program Development
      • Program Development

        We look at your projects in a global context. Biorasi’s consulting services are built around the idea that trials only realize their maximum value when they part of an optimized and effective holistic drug development program.

  • Therapeutic Areas
    • Autoimmune
      • Autoimmune

        Autoimmune is one of the fastest-growing areas of clinical research, due to increased recognition and incidence of autoimmune diseases i. Biorasi can help with all aspects of managing your next autoimmune trial.

    • Dermatology
      • Dermotology

        Dermatology trials have some very unique challenges. From difficulty in enrolling to compliance in a patient population that is typically much younger than other trials, Biorasi knows how to make your dermatology trial a success.

    • Nephrology
      • Nephrology & Pain

        Biorasi is a leading CRO in nephrology and dialysis-dependent CKD populations. No one understands the nuances of research in the dialysis population better than we do, and no one conducts these studies with our level of professionalism, and attention to the special needs of these patients.

    • Neurology
      • Neurology Trials

        Biorasi’s project managers and clinicians understand the complexities of neurodegenerative, pain, and psychiatric disorders. Our unique positioning and experience, coupled with our strong network and relationships with specialized sites give us an unparalleled advantage in neurology trials.

    • Oncology
      • Oncology Trials

        Many CROs specialize in oncology, however few have the versatility to offer full-service trial management like Biorasi. Find out how our integrative approach to oncology makes a real difference in the success of your next oncology trial.

    • Women's Health
      • Women’s Health Trials

        Trusting your women’s health trials to an expert like Biorasi guarantees every trial you run will be optimized. With years of experience and a broad portfolio of past studies, Biorasi is your best partner in women’s health clinical research.

    • Medical Devices
      • Medical Device Trials

        Medical devices are a unique field with a unique approach to regulatory approvals and clinical trials. Biorasi combines deep expertise in the specialized area of medical devices, and combines it with decades of therapeutic area excellence with our industry leading methodology.

  • Technology
    • Talos Technology

      An increasingly connected world can make your clinical trials better or just more complex. Our TALOS™ Technology Platform is built to take connections and turn them into insights, increase efficiencies and help us deliver optimized solutions for every sponsor.

      Learn More

  • Resources
  • Contact

The liver does many important things in the body, such as filtering of the blood and metabolizing all compounds, including food and drugs, that enter the body. In that vein, liver disease can be absolutely devastating.


Non-alcoholic fatty liver disease (NAFLD) affects almost 100 million, or around 25%, of people in the US alone, and the economic burden is over $100 billion annually, yet treatments are surprisingly limited. Treatment focuses mostly on reducing body weight, since obesity and metabolic syndrome are strongly associated with NAFLD, or resorting to a liver transplant. Those are not very good options, since weight loss is tough to achieve and maintain while liver transplants can mean serious wait time and lifelong immunosuppression afterwards. Without reversing the NAFLD fat accumulation in the liver, progression to non-alcoholic steatohepatitis (NASH) is a real and fatal possibility.


No drugs have been approved by the FDA to treat NAFLD or NASH. The only pharmaceuticals currently used to treat the diseases are geared more towards improving the comorbid insulin resistance that most patients have. For such a serious, chronic disease affecting so many people, that is simply unacceptable. Fortunately, there are some promising studies being conducted right now with numerous companies invested in the race. According to BioPharma Dive’s estimates, there are about 50 NASH candidates in phase I-III trials. Of course, only a small percentage of these, if any, will move forward in the pipeline.


Why is there such a large gap to fill in this indication?

  • NASH cannot be diagnosed without a liver biopsy, and doctors don’t want to biopsy a patient’s liver without a very good reason. For this reason, it’s likely that many patients also go undiagnosed, but then those patients wouldn’t be prescribed a drug for treatment.


  • NAFLD is a silent disease. There are few to no clinical symptoms of NAFLD or NASH until the later stages where damage to liver tissue is severe.



  • The development pathway with respect to regulatory approval is unclear because it’s so untraveled.


  • NASH is highly comorbid with diabetes and hypertension, so death or medical events from those diseases may be more likely to manifest sooner. Those diseases have thus received more attention from both physicians and pharmaceutical companies.


  • The lack of knowledge of the pathways that cause and regulate NAFLD is a major cause for the lack of drugs in the market. We don’t know what to target because the basic science is underdeveloped compared to other indications.


For all of these reasons, pharmaceutical companies may be hesitant to take on these drugs in their pipelines. Risk may be high, but payout could be great for the first drugs on the market to treat NASH or NAFLD.

Some of these challenges can be mediated, though, such as those that ensue from studying patients who have comorbidities. We plan to discuss how to overcome these challenges in the next few weeks, so stay tuned!

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