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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

    • 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

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 been based on the assumption that we should be pretty similar and that the average person represents all of us. Nevertheless, our genes, lifestyles, and lots of other factors can cause our blood glucose levels to be a little different from person to person. This is called variation, or the spread of data points, and it is minimized as much as possible in research by trying to figure out what is causing small differences. When variation is too large, it is difficult to see clear differences between groups that are supposed to be different. For this reason, anytime variation exists and is not well-accounted for, it can hide the true results of an intervention, meaning that a clinical trial can be a bust. Precision medicine, while seemingly just a buzzword to most people, is a revolutionary strategy to deal with all this variation. This newer approach to medical research is quickly advancing the field of cancer therapeutics. Naturally, these advances introduce new challenges for researchers, such as evolving regulations and experimental design.

Traditionally, cancers have been labeled based on where they originate in the body. For example, lung cancer is so named because it began in the lung tissue, even if its metastatic cells were first discovered in the liver. It is then treated as lung cancer. The problem with this style of characterization is that lung cancer can be very different from person to person; tumors can have mutations in different genes, such as the TP53, EGFR, or KRAS genes, and these mutations can depend on the individual person’s own genetics and/or the tumor’s own unique exposure to environmental insults. Each type of tumor can also respond differently to the same treatment. This is one of the reasons that drugs targeting tumors of the “lung” can work for some people but not for others. A better solution, theoretically, is to determine the abnormal genes of a tumor and administer a treatment that deals directly with those abnormalities. This is where precision medicine comes into play.

Some newer cancer trials, like the NCI-MATCH trial, are in fact designed to enroll participants with varying types of cancers and give a treatment based on the genetics of the tumor(s) they have rather than where the tumors originated. This is done by taking a biopsy of the tumor, using molecular methods such as sequencing to identify errors in the genes within the tissue sample, and then deciding on a treatment that is designed to target the abnormalities (e.g. mutated genes). This is in contrast to studies that enroll participants with one type of cancer to test one drug. For example, crizotinib was approved in 2011 specifically to treat metastatic non-small cell lung cancer. In the NCI-MATCH study, crizotinib is assigned as the first treatment for any tumors that contain a mutation in the MET, ALK, or ROS1 genes, not just tumors that originated in the lung. It was the basic science studies used to determine the mechanism of crizotinib that allowed for this novel, targeted application of the older drug. This strategy is referred to as a biomarker-driven design since the abnormal genes are serving as biomarkers for certain types of cancers. The FDA is onboard and has begun publishing guidance to help with this new type of strategy.

As with anything else novel, precision medicine is introducing new challenges to researchers. Protocols can be very long and complex. For example, the current NCI-MATCH study assigns patients to 1 of 30 subprotocols. Additionally, there are no control groups built into the design of this study, meaning that some of the results seen so far may have occurred anyway even without the drug. However, retrospective estimates of morbidity and mortality without any treatment are higher than those seen with the drugs, and this is the comparator that is often adopted to show some amount of efficacy in these study designs rather than the gold standard control group. Regulations are also changing to moderate these different types of protocols and study designs.

How will the pharmaceutical industry be affected by this change in direction? There is now much work to be done and a wide-open niche for pharmaceutical companies to develop new, more specific drugs. Regulations, technology, and our understanding of biology is changing rapidly, and it can be difficult to keep up. Pharmaceutical companies need a knowledgeable and agile clinical research partner that is familiar with cutting edge approaches to be able to fully embrace the shift to precision medicine.

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