• 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

Have you heard of virtual clinical trials? They are trials in which patients can do most of their study activities from home instead of traveling to a study site. A true virtual trial would thus eliminate the need for study sites and would rely entirely on remote monitoring and on-demand medical services when needed. At Biorasi, we have been wondering if it is really possible to design a trial to be completely virtual and what that would entail. These questions are the subject of our next white paper, which will be released later this year. For now, we have decided to feature some interesting technologies that could be put to use in a virtual, or maybe semi-virtual, trial.


  1. Portable electrocardiogram (ECG) monitors: AliveCor boasts an “FDA-cleared, clinical grade ECG monitor” that comes with an app for either an Apple Watch or your phone. With either system, the technology is able to construct a valid heart rhythm and interpret it as either normal or abnormal. This has far-reaching implications in medicine alone, as this can allow for early detection of dangerous heart arrhythmias, but there is also a huge potential for generated data to be used in clinical trials. Similar devices can detect other vitals such as heart rate, blood pressure, blood oxygenation, and body temperature.
  1. An eye lens that can measure circulating glucose: These have been in the works for a while, but previous versions were brittle (could easily break and cause damage to eye) or translucent/opaque (could block some vision). Jang-Ung Park’s lab at UNIST developed a lens that broke through these barriers and can communicate data wirelessly for monitoring. They state the lens could be used to measure glucose in diabetics, and this would certainly be the least invasive method available to do so. The eye seems an appropriate place to measure glucose, since high concentrations in this area are what lead to loss of vision in diabetics.
  1. A wristwatch that measures blood alcohol content: Need to know your blood alcohol content? Or do you need to know your patient’s blood alcohol content? BACtrack’s SKYN can be either integrated with an Apple Watch or worn as a standalone wristband. This wearable device senses the concentration of alcohol in sweat, which is related to the concentration of alcohol in blood. What better place to get a good sample of sweat than under your watch strap?
  1. Wi-fi enabled smart scales: There are many of these types of scales available, but people don’t seem to talk about them as much. Simple yet sophisticated, these scales offer convenient, accurate, real-time measurements of one of the most important health outcomes: body weight. But they can do so much more than that. Some also claim to measure fat mass, water percentage, and bone mass. Some even have a pregnancy mode for tracking expected changes in weight over time.
  1. An ingestible sensor that tracks medication compliance: Last year, the FDA approved a device-drug combination that incorporated Proteus’ ingestible sensor, a device the size of a “grain of sand.” When a drug is consumed that has been manufactured to have this sensor attached, the sensor communicates to a patch worn on the skin near the stomach, signaling that the medication has been taken. This signal is tracked in an app on your phone, and the patient can choose to share the data with family members and healthcare providers. Importantly, studies to show whether the device improves compliance are needed, and this could conceivably be measured. The device allows for compliance to be assessed objectively. On top of that, an app like this could be configured to send the patient reminders to take meds if they forget. All of this is helpful in improving both medicine and research. What more can you ask for?


When validated, calibrated, and functioning properly, these devices allow for more accurate measurements, more frequent measurements, immediate incorporation of data into an electronic data capture (EDC) system, and minimal effort of the research participant. The cost may be higher for some of these technologies compared to current standards of care, but as they are incorporated into medical practice, insurance companies may start to see the value in reimbursing for such devices. Transmission of data over secure servers is important to protect health information, and this requires vigilance and experience to be able to collect clinical trial data with these wireless devices.

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