• 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
    • Study Rescue
      • Study Rescue


        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

    • Clinical Services
      • 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.

    • 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.

    • Regulatory Services
      • 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 Science/Biometrics
      • 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.

    • 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.

  • Therapeutic Areas
    • 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.

    • Dermatology
      • Dermotology

        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.

    • 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

Stem Cell therapy constitutes one of the most hailed advents in medicine for its potential in treating many of the chronic and difficult diseases like Traumatic Brain Injury, Diabetes and Cancer. However, a huge cloud of myths and misconceptions surrounds this topic, alienating the public from embracing them as a viable option for disease treatment despite the promising results seen in pre-clinical and clinical trials. Here we will debunk some of the misunderstandings in an effort to demonstrate the potential these cells bring to the future of medicine:


Myth #1: All Stem Cells are the same.

False. When people hear the words “Stem Cells”, they typically think Embryonic Stem Cells. A lot of people don’t know that Stem Cells can originate from a number of sources. Embryonic Stem Cells come from embryos and are omnipotent, meaning that they have the ability to turn into any cell type in the organism. Adult Stem Cells come from reservoirs in the postnatal human body like bone marrow, adipose tissue (fat), teeth, etc. These differ in their ability to become different types of cells in the body depending on their source, age and other factors. Induced Pluripotent Stem Cells come from the manipulation of adult, fully-differentiated cells, like white blood cells and skin cells, which are subsequently induced to reprogram back to become Embryonic-Like Stem Cells with a very strong pluripotency capabilities. Majority of experimental treatments and translational research these days use either Adult or induced Pluripotent Stem Cells.


Myth #2: Using Stem Cells is unethical.

We try not to take sides in public debates about these kinds of ethical questions, but this particular myth is also false. Embryonic Stem Cells have stirred quite an ethical controversy due to killing the human embryos which they are derived from. However, the medical research community has steered away from this controversial arena more recently and focused efforts on using Adult and induced Pluripotent Stem Cells in treating diseases. Indeed, many of these efforts reached clinical trials very successfully in terms of safety and efficacy. In fact, as we mentioned in the last post, currently active experimental treatments and research overwhelmingly favor Adult Stem Cells and induced Pluripotent Stem Cells. As it turns out, Adult Stem Cells and induced Pluripotent Stem Cells are not only free of ethical controversy (since they’re made from donated material from a consenting adult, usually the person undergoing treatment), but they actually seem to be much more effective and have fewer side effects.


Myth #3: Stem Cell therapy carries the risk of rejection.

False. Since the medical community is focusing on the use of autologous (from self) sources of Adult and induced Pluripotent Stem Cells for therapy, the risk of rejection is almost non-existent. Even allogenic (from non self, exogenous) Stem Cells that are used in clinical trials have been proven to elicit no immune response as it is the case with the SB623 cells. The biggest risk preventing these therapies from reaching the public is the very minimal possibility that these cells would become cancerous cells. However, recent advances in Stem Cell research show an outstanding degree of control while generating these cells which helps ensure cancer-free stem cell therapy.


Myth #4: Stem Cell Therapy is FDA approved

Not yet. As mentioned earlier, Stem Cell Therapy is still in clinical trials for many indications such as Traumatic Brain Injury, Diabetes, Myocardial Infarction, Macular Degeneration, Parkinson’s disease, etc. Indeed, the FDA has recently cracked down on many clinics claiming the use of Stem Cell Therapy for certain indications that have not been validated through rigorous clinical trial processes. Nonetheless, one can imagine the plethora of proven and effective therapies that will be reaching the public in the coming years.

Considering the safety profile and potential benefits that Stem Cell Therapy presents for a wide range of disorders, it becomes imperative to better educate patients about Stem Cells and their use. Education would clarify a lot of the problematic misconceptions patients usually have, which would provide grounds for enhanced clinical trial participation based on a well-informed decision. That, in turn, could greatly increase the availability of life altering treatments across a wide variety of conditions, and improve quality of life for millions of people.

Biorasi is 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 2018 Biorasi, LLC. All rights reserved.

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