• 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

    • 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

“What we need to do is to keep working on getting biomarkers more defined to be able to differentiate between the different etiologies. This is going to be the path forward.”

Chronic kidney disease (CKD) is actually 20 times more prevalent and 100 times more lethal than cancer, but it does not get nearly as much attention or funding. In 2017, there were 16 FDA drug approvals for oncology compared with 1 for nephrology.

Wayne Bowden, Biorasi’s VP of Program Development, has overseen the initiation of many CKD trials. He was invited to speak on a panel at a conference last month in Raleigh, North Carolina entitled “Nephrology Clinical Trial Best Practices Master Class.” This conference was unique in that it brought together people from pharma, biotech, CROs, healthcare, and academia.


Here are some take-away messages from the panel discussion:

1. Treat the different diseases differently. CKD is still viewed by many as a single disease with many subtypes, but with constant reclassification and basic science research advances, we are finding that it is inappropriate to lump them together as one. Dr. Barbara Gillespie, who moderated the panel discussion, suggested that we call them “CKDs” instead.

2. Continue to support basic science research. We do not know nearly enough about how to differentiate between these different types of CKD. Right now, physicians often have to look for very small details in histological samples in order to properly diagnose. Biomarkers often present the easiest and clearest path for accurate diagnosis, but we do not yet have enough evidence on biomarker specificity for widespread use. GFR and creatinine are not specific enough. As Mr. Bowden stated at the panel, “What we need to do is to keep working on getting biomarkers more defined to be able to differentiate between the different etiologies. This is going to be the path forward.”

3. Listen to what patients consider relevant health outcomes. Patients do not care what their GFR is. They care about how fatigued they feel and how swollen their ankles are. GFR is easier to measure and more objective, so that’s why it has won out as an outcome, but sponsors must remember that patients won’t commit to a 5-year-long study that doesn’t promise to improve some of the things that they care about.

4. Collaborate with academics to write more effective and feasible study protocols. Academics see the patients and know what they can and will take on, but they don’t talk to stakeholders. Sponsors are very attuned to stakeholders’ needs, which is necessary, but they don’t always know what’s most important to the patient. Isn’t the drug being developed for the patient? Collaboration is the only way to remediate this.

5. Tell patients how severe their renal disease is by using numbers. The point was made that patients with diabetes know what their HbA1c is at any given moment. Why don’t patients with CKD know their GFR? Give them numbers. Tell them that they have stage 2 kidney disease. Get them to know their numbers. Point-of-care devices that measure GFR may be in order. The disease may not have any symptoms early on, but if patients were better aware of the direction they were headed in, they may be more proactive with treatment and may be inclined to participate in clinical trials.

6. Screen for kidney disease. Can you believe that 94% of patients with hypertension and 61% of patients with diabetes are not routinely screened for CKD? These are two of the strongest risk factors for developing CKD. This could be because the tests are costly and time-consuming, but earlier detection and management of CKD may offset this cost if patients are able to take more preventive measures and have more productive years of life.


The CKD community has set some lofty goals for the coming years. There are hopes to enroll 30% of patients with CKD in a clinical trial by 2030. This is important to create a more substantial research base for CKD. On a positive note, we are making advances that will help with this, such as more comprehensive patient registries, so this goal may actually be attainable.

Another important consideration brought up by Dr. Gillespie is that sponsors may have a hard time estimating their market size and return on investment, since most patients are not aware that they have CKD. This makes it difficult for sponsors to rationalize investing in CKD trials. The most simplistic solution for this might be to make the patients better aware of their disease.


We are sharing in your excitement for ASN’s Kidney Week later this month! We will be in San Diego and hope to see you there.

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