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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 Blog

Bookmark this page to keep up with all of the latest going on at Biorasi and to stay up-to-date with our Industry. Use the search to the right to search our archives.

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 per the US standard, fewer than 200,000 Americans must be affected by the condition, or per the EU standard, fewer than 1 in 2000 Europeans must be affected. That is still a significant number of people.   Unfortunately, many rare …

Read More »
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 being developed to treat the disease. In this blog, we present a couple of highlights from the guidance.   The new draft guidance very heavily pushes for development of less invasive biomarkers that can be used to diagnose and prognose …

Read More »
AdobeStock_213934977

Six Things We Can Do Now to Advance Clinical Research in CKD

“What we need to do is to keep working on getting biomarkers more defined to be able to differentiate between the different etiologies. This is going to be the path forward.” Chronic kidney disease (CKD) is actually 20 times more prevalent and 100 times more lethal than cancer, but it …

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Womens-Health-Blog-Image

The Tumultuous History of Women’s Involvement in Clinical Research

Inclusion of women in clinical research has a surprisingly colorful history. As you can probably imagine, inequality is present throughout, but for reasons that may not be so intuitive.   If you haven’t heard of the thalidomide crisis, here is a brief synopsis. In 1957, thalidomide was put on the …

Read More »
Alzheimers-Blog-01

Managing Alzheimer’s Trials in a Diverse Global Environment

Patients with Alzheimer’s are not treated the same everywhere. On a global level, this is immediately evident between countries through differences in diagnostic criteria. Even on a more local level, racial and ethnic disparities persist. These and other factors result in different standards of care. Multinational or not, study sites …

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Virtual Trials

Five New Tech Options to Use in your Virtual Trial

Have you heard of virtual clinical trials? They are trials in which patients can do most of their study activities from home instead of traveling to a study site. A true virtual trial would thus eliminate the need for study sites and would rely entirely on remote monitoring and on-demand …

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Design

How are Adaptive Trial Designs Improving Efficiency in Clinical Research?

The ability to adapt is a valued attribute in today’s constantly changing world, and clinical trial designs are no exception. Adaptive trial designs can save sponsors significant time and money, but they need to be approached with caution and planning.   Historical context Study design used to be straightforward and …

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Doctor

Reservations Held by Referring Physicians in Clinical Trials

Some physicians are reluctant to participate in clinical trials as a referring physician. This is a huge issue because a large portion of participants can come directly from a referring physician’s office. Referring physicians hesitate to get involved in research for several reasons. One of the main reasons is that …

Read More »
Beach Dog

Five Lesser-known Facts about Sun Exposure

Labor Day weekend is upon us! This means that many of us will be outdoors, if we’re lucky. Methods for preventing sun damage have not changed much in a while: cover up, use sunscreen, avoid tanning beds. Here are some things you may not have known about the sun and …

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Summer

Don’t Let Summer Obstacles Catch You Off Guard

There are physiological and logistical challenges to running studies in the summer. We present some solutions.

Read More »
Academic

Biorasi Joins Nova Southeastern University to Spur Healthcare Job Growth in South Florida

Leading Florida-based Contract Research Organization Partners With University to Train Tomorrow’s Medical Research Professionals Miami, FL, Aug. 09, 2018 (GLOBE NEWSWIRE) — Biorasi, a leading full-service global contract research organization (CRO), is excited to announce two new certificate programs through Nova Southeastern University to provide targeted education and job skills …

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Light Bulb

Eight Sponsor Essentials for a Successful Clinical Trial

It’s pretty common for a pharmaceutical company to have a list of demands ready when choosing a CRO partner for a clinical trial. Here at Biorasi, we have some demands of our own that we consider non-negotiable and vital to the success of any trial.

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Precision

Using Precision Medicine in Cancer Trials

Why is it that when we take 50 people of similar height and weight and measure their fasting blood glucose, we get 50 different results? Shouldn’t they be pretty much the same, since we are all humans? The answer to this may seem obvious, but a lot of science has …

Read More »
Wearable Tech

The Future is Here for Clinical Trials, and It Introduces New Risks

Mobile phone apps and wearable devices have a lot of potential to improve clinical studies. However, the rules governing them are complex, varied, and not fully developed. It is important to be vigilant and remember best practices before rushing out to jump on the latest and greatest. Failure to do …

Read More »

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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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