• 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

Meet the Biorasi Team

Clinical Research Optimized™ begins with hiring the best – from industry and regulatory agency veterans, to promising young talent on the rise.  It continues with rigorous training using the TALOS™ platform, an integrated tool that keeps every one of our employees operating at 100% all of the time. We foster talent with our unique mentoring program and reward everyone with a stake in our company.  Finally, Clinical Research Optimized™ hinges on strong leadership with a defining vision for our company and with unparalleled commitment to excellence in the services we provide to our sponsors and partners.

  • Biorasi is an employee-owned company, which aligns our employees’ goals with our sponsors’ goals.
  • We operate on a model of office-based teams to give us maximum flexibility and agility in building out teams for each individual trial we run.
  • Biorasi’s human resources infrastructure was designed from the ground up not just to work, but to work for our sponsors.

Boris Reznik, PhD

Boris Reznik, PhD, is a veteran of multiple startups and is backed by a track record of building companies across a diverse set of industries. Dr. Reznik leads Biorasi with a strong focus on processes and systems – a unique perspective in the CRO world.

Lindsey Rios

Senior VP, Project Operations
Lindsey Rios has been with Biorasi for nearly ten years and understands complex projects better than anyone. Ms. Rios heads up a large, geographically dispersed team and contributes heavily towards Biorasi’s operational excellence.

Gary Urban

Senior VP, Process & Quality
Gary Urban comes to Biorasi after decades of experience in management and technology consulting. His insights and experience guide Biorasi’s continuous improvement. Mr. Urban is also the lead architect of the TALOS™ platform.

Jon Roth

VP, Data Sciences & Biometrics
Jon Roth is an early pioneer in electronic data processing for clinical trials. Mr. Roth’s experience is a crucial component of Biorasi’s success as a data and bioinformatics leader.

Mark Vieder

VP, Drug Safety and Pharmacovigilance
Mark Vieder comes to Biorasi by way of an exemplary career with the FDA, along with safety and regulatory positions at some of the biggest names in commercial pharma.

Hartmut Schmied

VP, Head of European Operations
Hartmut Schmied has over 25 years of experience in clinical research. He held high-level strategic positions in Project Management and Medical Affairs in the pharmaceutical and CRO industry.

Wayne Bowden

VP, Program Development
Wayne Bowden is an accomplished researcher and executive, combining the scientific knowledge to understand the most intricate details of clinical research and the business experience to shepherd those trials to success.

Alexandre Mouravskiy

Chief Marketing Officer
With over a decade of marketing experience, including work with international brands like McDonald’s, Midmark/Steris, and Las Vegas, Alexandre heads Biorasi’s industry-leading marketing efforts. Mr. Mouravskiy has won numerous awards and honors for his work.

Joe Wall

VP, Marketing
Before joining Biorasi, Joe held Digital Planning & Strategic Marketing leadership positions in Healthcare and Casino/Resort businesses. He has been instrumental with leveraging the digital technology evolution for business growth.

Ine-Mari Bornman

VP, Clinical Services
Ine-Marie Bornman is a clinical research professional with 15+ years of industry experience at Sponsor, CRO, and Site levels. Mrs. Bornman has a background in Intensive Care Nursing, is certified in Project Management, and is an SME in technology-driven clinical research.

Nilu Celenk

VP, Project Management
Nilufer Celenk has over 17 years of operations and project management experience. Her responsibilities include building out Biorasi’s project management team, as well as leading sponsor projects.  She holds an MBA from Loyola University and a B.S. from Istanbul Technical University.

Download a Sample Rescue Trial Report

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