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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

Despite an extremely encouraging 38% decrease in mortality since 1989, Breast Cancer remains the most common type of cancer in the US. Indeed, it is estimated that in 2017, there will be 252,710 new cases of invasive breast cancer and over 40,000 breast cancer deaths among US women. These numbers highlight that:

  • The medical community is successfully introducing new treatment regimens for women afflicted with Breast Cancer
  • Much more needs to be done to decrease the number of deaths due to Breast Cancer

To address the latter point, the medical research community is relentlessly working on novel treatments that must be validated through clinical trials in order to bring efficacious ones to market. Unfortunately, despite an increase in the number of clinical trials conducted nationwide, less than 5% of women with breast cancer enroll in them.

Over the years, a number of reasons have been attributed to the lack of breast cancer clinical trial enrollment. These include mistrust of the health care system, patient bias against clinical trials, other comorbidities, insurance difficulties related to either the lack of or the presence of a non-comprehensive policy coverage, transportation issues and restrictive eligibility criteria.

Other reasons affecting enrollment are inherently related to the disease itself:

  • New Breast Cancer drugs and modalities (i.e. immunotherapy) may have secondary effects that could alter the patients’ quality of life, like pneumonitis, pancreatitis, skin rashes, nausea and vomiting, diarrhea or constipation, mouth sores, shortness of breath or trouble breathing, cough, chronic fatigue and headache
  • Since many of the novel proposed treatment regimens are administered in combination, clinical trials are designed with growing complexity. Thus, potential Breast Cancer patients are increasingly reluctant to enroll due to overwhelming complexity of trial procedures
  • Early stage Breast Cancer patients have a relatively high rate of success following current treatment options. In contrast, patients with more advanced disease – and fewer standard treatment options – are more likely to consider clinical trials compared to those with earlier stages of the disease. This leads to lower participation numbers in trials targeting early stages of the disease, which in turn affects the timeline and success of those trials and delays potential successful treatments from reaching the public in time before the disease evolves to later and more invasive stages

These enrollment issues are complex and far-reaching. As a response, studies have repeatedly emphasized that the best way to mitigate this complexity is through robust patient education. A recent prospective patient survey highlighted that public education on the true value of clinical research and the reality of participating in a clinical trial is seriously lacking. Therefore, involving trained patient advocates at each step of the clinical research process, even in pre-clinical phases, could provide significant benefit in helping to design informative trials, as well as recruit patients to participate.

For example, many of those cancer patients presented common misconceptions about clinical trials like confusing sham treatment with no treatment when in reality it represents the currently approved standard of care. Educating this group of patients about comparing new drugs to actual standard care drastically alleviated their concerns. As a proof of principle, another study clearly showed significantly enhanced participation due to increased involvement of well trained and informed nurses in explaining clinical trial options to the patients.

Barriers that keep clinical trial participation low should and can be broken. The Breast Cancer community as a whole, including patients, medical professionals, advocates, families and friends should unite behind the common goal of increasing education for patients to enhance clinical study enrollment and participation, which can bring us closer to identifying better treatment options.

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.

CONTACT INFORMATION

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