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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.

Blog-01-17-19

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 industry we are seeing increasing interest in trials that don’t require sites. Instead, many sponsors are beginning to plan trials where all patient data is gathered electronically directly by the patient. So what if participating in a clinical trial didn’t …

Read More »
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 the topic while highlighting a few of our subject matter and operations experts. Over the next few months, we will be diving into dermatology, covering topics ranging from specific challenges in this therapeutic area to current technologies that are a …

Read More »
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 …

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 …

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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 excited to announce that it has successfully closed an investment transaction with Riordan, Lewis & Haden | Equity Partners, a private equity firm based in …

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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 their blood glucose levels. Management of type 1 diabetes has traditionally been cumbersome, time-consuming, and expensive, so better treatment methods are sorely needed.   For …

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Lab

A Deep Dive into NASH Physiology and Drug Targets

In the clinical trial world, we spend a lot of time focusing on phase I-IV trials, and it’s easy to forget about the very important preclinical, basic science studies that go into drug development.   Many pharmaceuticals are developed from basic science studies, or studies that attempt to define molecular …

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Teamwork2

How Managers Can Establish Good Working Relationships with their Internal Team

Authors: Geetesh Shrivastava, Associate Director of Clinical Monitoring; Jennifer Dennis-Wall, PhD, Lead Scientific Writer Back in August, we published a blog addressing themes that are important for sponsor partners to follow so that we as a CRO can provide them with the best possible service. To complement those themes, we …

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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 …

Read More »
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 …

Read More »
Map

10 Lessons On Success in Asia-PAC Trials from DIA 2018

Earlier this year, a few of us attended DIA 2018 to represent Biorasi. While there, we were fortunate enough to be able to give a talk about some of our experiences entitled “Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams” in collaboration with Brian J. Malkin, …

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Eye

You’re Holding Your Eye Drops Wrong – What Makes Ophthalmology Trials so Challenging?

Last week, one of our resident experts in ophthalmology, Ignacio Handal, gave a training for some of our current studies with a focus on which pitfalls to avoid specifically in ophthalmology trials. He dished out many fun facts and eye-opening insights.   Compliance is difficult enough to achieve for any …

Read More »
Breast Cancer Awareness

A More Complete Scope for Advances in Women’s Health

When people think about women’s health, especially during the month of October, they may think only of breast cancer or reproductive disorders. The truth, though, is that women’s health encompasses so much more. The field of medicine pertaining to women’s health is rapidly growing to include the study of both …

Read More »
Gears

The Politics of Investigator-Initiated Trials

Many clinical trials are initiated by a pharmaceutical company in order to generate data to submit to the FDA for drug approval. Investigator-initiated trials (IITs), on the other hand, are conceived by a clinician and not by the company that plans to sell the drug or device under study. IITs …

Read More »

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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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