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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
    • 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

    • 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

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 those of us who are living with or who have a family member living with type 1 diabetes, we are probably well acquainted with the promises of pancreas transplants, islet stem cell therapy, and other science fiction. But what types of advances can we realistically hope for in the next 5 to 10 years? Or maybe even in the next 2 years?

 

Current, well-established options that are still pretty sci-fi

We have really come a long way in producing tools and medications to more easily manage diabetes. Insulin pumps and continuous glucose monitors are now pretty common and are generally covered by insurance, which is a huge step from traditional syringe-and-vial shots of insulin. This traditional method relies on the patient guessing how many carbs they just ate, the patient’s ability to properly load a syringe, and hefty trial and error when the carefully measured doses don’t give the expected result of a healthy blood glucose level.

 

Two years ago, the FDA actually approved an artificial pancreas system that monitors blood glucose and injects insulin in response to glucose changes, keeping glucose levels in a more optimal range more often. The technology is not quite good enough to replace all insulin shots, since patients must still give themselves calculated doses of insulin at mealtime, but researchers are working on this. One of the major things to worry about with this system is coming into contact with magnets or radiation, which can result in calibration and serious dosage issues. This system is available by prescription.

 

Experimental treatments that show true promise

Pancreatic islet transplantation is happening now in experimental conditions and is not available for everyone, but initial results have been positive. One of the major downsides to this procedure is having to take immunosuppressants so that the body’s immune system doesn’t attack the foreign objects (the transplanted cells). There are, however, scientists working on solutions to this that may remove the need to take immunosuppressants. Pancreas transplants come with high risks and are not indicated for patients with type 1 diabetes unless they have already had another organ transplant (e.g. kidney) and are already taking immunosuppressants. Risks and downsides of a full pancreas transplant include taking life-long immunosuppressants, possible infection or other complications from the surgery itself, and the expense. Plus, a healthy pancreas is hard to come by, so wait lists could be long.

 

One group of scientists claims to be able to predict with “almost 100% accuracy” who will develop type 1 diabetes based on a genetic predisposition involving the HLA-DQ8 gene. That alone is science fiction. Some medications, such as a blood pressure medication called methyldopa, are being used in clinical trials to inhibit the process that is thought to lead to progression of diabetes via this gene. The current research on this, however, is limited to small-scale trials and needs to be confirmed with larger sample sizes; the next study is already planned to begin in 2019.

 

The real bottom line

New technology is great, but if it is only just as good as what is already on the market, is it really helping anyone? Noninferiority studies for new devices will only go so far in truly helping people with diabetes. Superior efficacy or improved quality of life measured with validated, reliable tools (or both) could be argued to be clinically relevant outcomes. Improving quality of life in these patients is especially important since the intensive treatment and management regimens are thought to possibly lead to the high incidence of comorbid psychiatric disorders. And, as always, research should strive to show safety and efficacy in larger, more representative samples to get a more accurate picture of how a drug or device will work in the real world.

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.

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