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  • 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

        PUTTING STALLING TRIALS BACK ON TRACK

        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

As wearables gain popularity and health related applications rank higher on consumer needs; the health-tech industry is rapidly evolving. 2012 marked the new era of “health-tech” with Sage Bionetworks launching voice recording apps to check for voice tremors in Parkinson’s patients. The company expanded initial innovations to include screen tapping tests and walking/balancing assessments utilizing a mobile phone’s built in calibration hardware. The first version of this software was introduced on the mobile Android operating system. Taking a look at the dominant Android market share; Sage made the logical decision for where to launch first. However, operating in a market with a mega-influencer such as Apple does create quite a conundrum for competition. The Apple Watch has created a significant buzz. Consumers probably do not know smartwatches touting the Android software were around long before Apple’s watch. Apple’s significantly smaller market share is the powerful minority in the mobile tech world. 9 March, 2015 Apple announced ResearchKit, an open source framework app which allows developers to create apps for medical research studies. The Pharmaceutical industry and Parkinson’s researchers stood and took notice of what this could mean and the positive impacts.

Smartphones provide a platform for objective testing, leading to a more fully complete scientific picture. Considering the years of development invested in the Parkinson’s assessment software for Android, an Apple version, mPower (Mobile Parkinson Observatory for Worldwide, Evidence-based Research,) was a natural choice for one of the first 5 built in apps launched with ResearchKit. The team at Sage Bionetworks partnered with Apple to bring what they had built on Android to the ResearchKit platform. The potential advantages of this new development on Parkinson’s research is unfathomable. While we have not discovered the underlying cause of Parkinson’s Disease, we do know it can’t be entirely genetic, behavioral or environmental. To advance research to the next step, we need detailed knowledge about behavior and the environment of each patient.

As part of the launch of the mPower app, the Michael J. Fox Foundation has announced Fox Insight. Fox Insight marks the moment clinical trials catapulted into a new era. This is huge. It is a Web-based virtual clinical study; open to individuals of any age, both with and without Parkinson’s. With an iPhone app, and an easy online registration, Fox Insight can turn every one of the 700 million iPhone owners in the world into a subject. The sheer amount of data collected is unprecedented. Later this year, the data collected from participants will be used to validate the power of these two approaches in accelerating Parkinson’s disease research.

Innovations in the health-tech world today are positioned to impact the community forever and are forecasted to result in breakthrough advances for Parkinson’s research and many other life impacting indications. We should stay tuned and well aware with excitement.

Click here to learn more about CNS Studies.

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