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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.

Site

Considerations for Working with Research-Naive vs. Experienced Sites

When recruiting patients with hard-to-enroll indications, such as rare diseases, it is sometimes necessary to dip into creative resources for finding sites. Sometimes this means looking across the ocean, or sometimes there may be opportunities in your backyard. Some sites have a lot of experience, and those are generally sought after, but they can be busy running other trials and may not prioritize yours. It …

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Liver

Why Aren’t There Any FDA-Approved Drugs to Treat NASH?

The liver does many important things in the body, such as filtering of the blood and metabolizing all compounds, including food and drugs, that enter the body. In that vein, liver disease can be absolutely devastating.   Non-alcoholic fatty liver disease (NAFLD) affects almost 100 million, or around 25%, of people in the US alone, and the economic burden is over $100 billion annually, yet …

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blog-post-graphic-biosimilars-supreme-court

The Decision on Timing in the BPCI Act

This week, the path to market for biosimilar developers cleared up just a bit. The Supreme Court made a final decision in the three-year lawsuit between Amgen and Sandoz that sets a precedent regarding the interpretation of some widely-contested language in the BPCI Act. The language in question referred to …

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Emerging-Challenges-in-Global-Clinical-Studies

Emerging Challenges in Global Clinical Studies

Clinical research is going global. This growth translates to sponsors no longer running separate studies in each and every country they are seeking marketing approval; instead they are opting for large, global studies that have percentages of the required subjects in each venue they desire for marketing approval. A major …

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Phoevos H. Pic

Biorasi Spotlight: Phoevos Hughes – Senior Project Manager

For this week’s Biorasi Spotlight, meet Phoevos Hughes, Senior Project Manager at Biorasi, LLC.   1. How did you get into clinical research? The short version – sheer luck. The long version… When I first decided that I had no interest in pursuing a legal career, I was living in …

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Alzheimers blog post

Advances in Early Alzheimer’s Detection

The prevalence of Alzheimer’s disease (AD) is rapidly increasing as individual life spans across the world increase.  It is currently the most common form of dementia, marked by the overproduction and aggregation of amyloid β (Aβ) and tau proteins in the brain. These aggregates may trigger various symptoms in the …

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Mari H. Pic

Biorasi Spotlight: Mari Heghinian, PhD – Manager of Program Development

For this week’s Biorasi Spotlight, meet Mari Heghinian, PhD, Manager of Program Development at Biorasi, LLC.   1. How did you get into clinical research? After graduating with my PhD, I joined the pre-clinical group in a small Pharma company. The company conducted bi-weekly calls to update on the progress …

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Big Data can help minimize risk in clinical trials

Can Big Data Rescue Clinical Trials?

If you had to pick one buzzword that perfectly encapsulated the current latest and greatest in innovation, you could do a lot worse than “big data”. The last few years have seen big data and data mining introduced into nearly every field imaginable, often with disruptive results. Now, that same …

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Biorasi Head of Safety and Pharmacovigilance Appointed to the DIA Faculty

MIAMI, FL – ( April 12, 2017) – Biorasi, LLC. announced today that their Vice President of Drug Safety and Pharmacovigilance, Mark Vieder, RPh, MBA, has been officially selected to join the faculty of the DIA (founded as the Drug Information Association). This appointment comes as a great honor for Mr. …

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3-Trends-in-Biosimilars--A-6-Year-Outlook

3 Trends in Biosimilars: A 6-Year Outlook

Over the next five years, the purchase and production of biosimilar drugs can expect to see double-digit growth. As biosimilar drugs become more widely produced, prescribed, used, and accepted, the competitive marketplace will continue to heat up. What are the drivers for biosimilar drug production? And what trends are having an …

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The-Most-Common-Reasons-for-Trial-Rescue-and-How-to-Avoid-it-in-the-First-Place

The Most Common Reasons for Trial Rescue and How to Avoid it in the First Place

The study is behind schedule. Enrollment is lagging. The protocol is too complicated. Approximately 80 percent of all clinical studies need intervention or optimization to be successful, but only about 10 percent get it. Why? Because there is an negative connotation to the term “trial rescue.” Some Sponsors don’t want to …

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Implement-CDISC-Standards-for-Faster-Reporting-and-Cost-Control

Implement CDISC Standards for Faster Reporting and Cost Control

The Clinical Data Interchange Standards Consortium (CDISC) created standards designed to streamline clinical research data and essentially enable reviewers to more fully assess the efficacy and safety of a product. In 2014, the FDA mandated that study data be submitted in conformance with CDISC standards. While research organizations are evolving …

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The-Promise-of-Biosimilar-Drugs

The Promise of Biosimilar Drugs

In 2006, the European Medicines Agency granted its first approval of a biosimilar drug, the human growth hormone, Omnitrope™ (Sandoz), and opened the doors of opportunity for this emerging field of medicine. In 2010, President Obama signed into law the Biosimilars Act, and on March 6, 2015, the FDA formally approved its first …

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Creating-High-Performance-Pharmacovigilance-Teams-in-Diverse,-Global-Environments

Creating High Performance Pharmacovigilance Teams in Diverse, Global Environments

Individuals often interpret the same information and terms in dramatically different ways. Multiple factors drive these variances, including culture, background, education, training, and personal biases. Unfortunately, this means when diverse global teams converge in Drug Safety and Pharmacovigilance environments, it can compromise the accurate capture and reporting of critical safety …

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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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