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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
    • 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.

    • 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.

    • Clinical
      • Clinical Services

        The Biorasi clinical team achieves unconventional results from rapid site startup, through successful completion of enrollment and the timely lock of the study database.

    • Regulatory
      • 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 Sciences
      • 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.

    • 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

  • Therapeutic Areas
    • Dermatology
      • Dermatology

        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.

    • 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.

    • 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

Biorasi Clinical Research Case Studies

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Tactful Strategies Steer a Failing Trial to Safety

Tactful Strategies Steer a Failing Trial to Safety Overcoming More Than Just Language Barriers The Challenge: Global studies are notoriously complicated with language barriers, time zone differences, and oft-contradictory regulations. These business challenges are exacerbated, not only working with multiple, but unique cultures. Biorasi encountered this scenario when we were …

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A Patient-Centric Approach Rescues Complex TBI Study

A Patient-Centric Approach Rescues Complex TBI Study Improving Communication to Boost Patient Retention The Challenge: Site selection is one of the most crucial parts of planning a study. Ensuring that sites are performing up to par while a trial is underway is equally important but often neglected. Biorasi was asked …

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Dermatology Expertise Helps Biorasi Recruit In Challenging Conditions

Dermatology Expertise Helps Biorasi Recruit In Challenging Conditions Intelligent Processes Overcome Enrollment Barriers The Challenge: Patient compliance was a serious concern, particularly regarding the reduction of sun exposure. Running a dermatology trial, especially in the middle of summer, can greatly affect patient compliance and the resulting, potential flare-ups in any …

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An Innovative Approach to Solve an RLD Shortage

An Innovative Approach to Solve an RLD Shortage Intelligent Project Management to the Rescue of a Scabies Generic Trial The Challenge: Limited or no availability of the Reference Listed Drug (RLD) for a generic dermatology trial can seriously hinder the feasibility of a study. This was exactly the case in …

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Strict Processes Rescue Complex MS Trial

Strict Processes Rescue Complex MS Trial Biorasi’s Project Management-first Approach Allows Rapid Feasibility and Site Startup to Meet Critical Deadlines The Challenge: A specialty pharmaceutical company engaged Biorasi to rescue their phase 2 clinical trial for treatment of spasticity caused by multiple sclerosis (MS). The incumbent CRO was not meeting …

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A Modern Approach to Patient education Increases Enrollment

A Modern Approach to Patient Education Increases Enrollment Interactive Solution Increases Enrollment And Compliance With Injectables Download Case Study The Challenge:Running a trial for dermatology injectables when topical alternatives exist presents unique challenges. Patients are reluctant to stick themselves regularly for what they perceive as marginal improvements over an alternative …

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Traial Planning Save ALBP Trial some Pain

Biorasi Rescue Effort Doubles CNS Trial Enrollment Rate Leveraging experience to predict problems before they affect clinical trial deliverables Download Case Study The Challenge:Not every study presents a completely new and unique set of challenges. That’s not to say that the trial is generic, or not complex, but rather that …

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Biorasi’s TALOS™ Platform and Unique Sites Win Unusual ANDA Trial

Biorasi’s TALOS™ Platform and Unique Site Win Unusual ANDA Trial Flexibility and Strong Process-driven Planning Overcomes Regulatory Speedbumps Download Case Study The Background:ANDA approval for therapies going off-patent are typically a staid affair. Timelines are established years in advance, procedures are standardized and well-tested, sites and patients are largely uniform …

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Trial Rescue Effort Doubles CNS Trial Enrollment Rate

BIORASI RESCUE EFFORT DOUBLES CNS TRIAL ENROLLMENT RATE Patient Enrollment Needs To Be Strategic, Not Just Tactical Download Case Study Almost every company that has ever run a trial finds themselves, at some point, looking at enrollment figures and wondering if they’ll meet their patient and site quotas on schedule. …

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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.

We are an award-winning contract research organization accelerating drug and device development for small- and mid-sized life sciences companies around the world.

Biorasi has over 200 employees in its headquarters in Miami, Florida, and in regional offices around the globe.

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