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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

Our educational components provide a glimpse into our culture, medical perspectives, future vision and direction. How we influence our audience reflects the impact on our sponsors and their patient, not only at the present, but also in the future.

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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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White Papers

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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 …

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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 …

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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 …

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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 …

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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, …

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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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Articles

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What Are The Advantages of Virtual Trials?

In this blog post, we will try to understand Virtual Clinical Trial. As technology continues to become better and more integrated into the clinical development …

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Dermatology

Introducing Biorasi’s Center of Excellence: Dermatology

Biorasi has a solid track record of experience in dermatology, and our goal for this year is to share all corners of our knowledge on …

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Rare Disease Awareness

Commonalities of Rare Diseases

Collectively, rare diseases affect a huge number of people: about 25 million in the US and 400 million globally. To qualify as a rare disease …

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Governing Body

New FDA Guidance for NASH Drug Development

Just in time for our final follow-up to the two previous articles on non-alcoholic steatohepatitis (NASH), the FDA released a new draft guidance for drugs …

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Office Building

Press Release: Biorasi Partners with RLH Equity to Spur Expansion and Growth

Florida-Based CRO seeks to expand offerings, global footprint, and headcount after successful investment transaction.   Biorasi, a leading full-service global contract research organization (CRO), is …

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Pediatric Diabetes

The Future of Diabetes Treatment

Type 1 diabetes affects millions of people in the US alone. What’s worse is that the majority of patients do not achieve good control of …

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Events

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AAD 2019

Biorasi will be attending and exhibiting at the AAD 2019 Annual Meeting from March 1-5 in Washington, DC. We would like to extend a cordial invitation to all of our partners, sponsors, and friends to come visit us at booth number 2455. We will be showcasing how Biorasi is a new kind of CRO in how we manage clinical trials, as well as providing information on our Rescue Study expertise.

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SCOPE 2019 Annual Meeting

Biorasi will be attending and exhibiting at the SCOPE 2019 Annual Meeting from February 18-21 in Orlando, FL. We would like to extend a cordial invitation to all of our partners, sponsors, and friends to come visit us at booth number 29. We will be showcasing how Biorasi is a new kind of CRO in how we manage clinical trials, as well as providing information on our Rescue Study expertise.

Request Information »
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DIA 2019 Annual Meeting

Biorasi will be attending and exhibiting at the DIA 2019 Global Annual Meeting from June 23-27 at the San Diego Convention Center. We would like to extend a cordial invitation to all of our partners, sponsors, and friends to come visit us at booth number 850. We will be showcasing how Biorasi is a new kind of CRO in how we manage clinical trials, as well as providing information on our Rescue Study expertise.

Request Information »

Got a question?

We have Experts available to answer your questions
Complete the form on the right or give us a call.

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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