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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 White Papers

Biorasi-How-Virtual-Trials-are-Revolutionizing-Clinical-Research-While-Supporting-Patient-Centricity-v0-02-COVER

How Virtual Trials Support Patient-Centricity

Revolutionizing Clinical Research: How Virtual Trials Support Patient-Centricity In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. Download White Paper

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Biorasi---Advanced-Analytics-for-Monitoring-of-Clinical-Trials-06-COVER

Advanced Analytics for the Monitoring of Clinical Trials

Advanced Analytics for the Monitoring of Clinical Trials What if there was a way to harness all this data we’re collecting and turn it into a strategic advantage for our clinical trials? Indeed, Biorasi’s data sciences team has found a way. Methods beyond risk-based monitoring are required for a more …

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Biorasi--Quintessential-Guide-to-Planning-a-Clinical-Trial-v0-7-SMALL

Quintessential Guide to Planning a Clinical Trial

The Quintessential Guide to Planning a Clinical Trial Clinical trials are complex undertakings, with complex planning required. Success or failure is often determined long before the trial even gets underway. Biorasi’s quintessential guide to clinical trial planning helps program managers and operations directors identify and resolve the sticking points that …

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Putting CDISC Standards to Work

White Paper – Putting CDISC Standards to Work

Putting CDISC Standards to Work The CDISC set of standards revolutionized data management in clinical trials by introducing a standardized model for data interoperability. The standard has been shown to decrease study data resource requirements by 60% overall, and 70-90% in start-up stages when implemented early. This results in dramatic …

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Operating a Pharmacovigilance Group in a Multicultural Global Environment

White Paper – Operating a Pharmacovigilance Group in a Multicultural Global Environment

Operating a Pharmacovigilance Group in a Multicultural Global Environment The way an individual interprets language is influenced by many factors, including culture, background, education, training, and personal biases. Download White Paper

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White Paper Covers6

White Paper – Optimizing Ophthalmic CE ANDA Trials

Optimizing Ophthalmic CE ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Navigating through the Clinical Trial Authorization Process in Russia

White Paper – Navigating through the Clinical Trial Authorization Process in Russia

Navigating through the Clinical Trial Authorization Process in Russia Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Patient Numbers Required In Clinical Endpoint ANDA Trials

White Paper – Patient Numbers Required In Clinical Endpoint ANDA Trials

Patient Numbers Required In Clinical Endpoint ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Optimizing the Amount of Investigational Materials PART TWO

White Paper – Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two

Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two For Dermal Semisolid Clinical Studies White Paper Series Download White Paper

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Optimizing the Amount of Investigational Materials PART ONE

White Paper – Optimizing the Amount of Investigational Materials in ANDA Studies – Part One

Optimizing the Amount of Investigational Materials in ANDA Studies – Part One Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper

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Biorasi---Rescue-is-Not-a-Dirty-Word-v1-5-1-small-cover

‘Rescue’ Is Not A Dirty Word: Embracing Early Intervention in Faltering Clinical Trials

‘Rescue’ Is Not A Dirty Word: Embracing Early Intervention in Faltering Clinical Trials Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In an analysis conducted by the Biorasi …

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Clinical Endpoint ANDA Program Optimization

White Paper – Clinical Endpoint ANDA Program Optimization Introduction

Clinical Endpoint ANDA Program Optimization This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry. We will be publishing these reports addressing and analyzing different aspects of optimization several times a year and …

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Biorasi - How to Better Manage the Complexities of Clinical Trials in the Dialysis-Dependent CKD Population-v0-3 (1)

White Paper – How To Better Manage the Complexities of Clinical Trials in the Dialysis-Dependent CKD Population

Managing the Complexities of Clinical Trials in the Dialysis-Dependent CKD Population Chronic kidney disease is a serious, slowly progressing condition, culminating in end-stage renal disease. Developers of treatments for this condition face a range of challenges in the clinical development process. Ensuring timely, quality, cost-effective execution of ESRD clinical trials …

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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.

© Copyright 2019 Biorasi, LLC. All rights reserved.  |  +1 786-383-0454

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