• 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

Partnering with our Sponsors' Challenges

Biorasi builds partnerships with our sponsors. Your challenge is our challenge. We identify with your unique needs and leverage our systems, methodologies, and processes to build optimal solutions for your unique trial. We place project management front and center in all of our solutions, leading to superior results for our partners each and every time.

Biorasi is a full-service, global CRO whose vision is a future where data, process, and technology work together seamlessly to accelerate drug development for the benefit of our sponsors and their patients’ lives.

How Biorasi Optimizes Clinical Solutions

Starting with your initial pre-trial discussion, Biorasi works in a systematic way to identify the specific challenges facing your trial, creating solutions that focus on your specific objectives. We believe that great project management, based on technology platforms, is the key to every successful trial. Biorasi has architected a set of systems, methodologies, and processes that allow us to be attentive, responsive, and results-oriented like no other CRO.

Disrupting Industry Standards

Take Control of your Trial

Our optimized solutions offer flexibility by leveraging a laser-focused approach to study design and implementation with our technology platform. Our TALOS™ Technology allows our sponsors to monitor the progress of their trial in granular detail, offering unparalleled transparency into our processes and the status of their trial. All trial data is aggregated into a single dashboard that provides our sponsors, and us, with everything needed to deliver a successful clinical trial. The business intelligence from TALOS provides the predictive insight and options that others may not offer.

Optimize your Engagement

Every clinical trial is unique and needs to be approached as an exclusive engagement – a one-size-fits-all “static solution” will never be fully optimized to meet a sponsor’s expectations. Today’s constant pressure from stakeholders, timelines, budgets, and regulators force sponsors to continually settle for suboptimal, cookie-cutter solutions. Biorasi provides solutions that aren’t just valid today – they are built to move sponsor trials forward no matter what the future brings. We prepare for what comes next, whether it be regulation, technology, trial design, challenges, or complexities. We anticipate the roadblocks. We don’t pretend to make the complex simple, but we can promise that we can move sponsor trials forward over any obstacle through our partnership with you.

Our Global Reach

With offices in most major regulatory jurisdictions, we have the ability to run trials across the world. Our geographic distribution has given us experience across a wide range of regulatory environments, and in our time in the industry, we’ve weathered all kinds of regulatory climates as well as global cultures. We understand that patients view their doctors as gods in some countries, while patients in the US may not be so compliant with the doctor’s advice. We know that some areas have frequent communications outages, and others are prone to work-stopping natural disasters during certain seasons of the year. Biorasi leverages our local knowledge to better predict the challenges and make informed decisions that continue accelerating trial completion and regulatory approval.

Contact Biorasi

Got a question? We’d love to hear from you.

Send us a message and we’ll be happy to answer all your questions.

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