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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

Inclusion of women in clinical research has a surprisingly colorful history. As you can probably imagine, inequality is present throughout, but for reasons that may not be so intuitive.

 

If you haven’t heard of the thalidomide crisis, here is a brief synopsis. In 1957, thalidomide was put on the market in Germany and a few other countries to treat morning sickness and other ailments. Then, throughout the next few years, thousands of babies suffered from severe birth deformities or early death. The birth deformities were attributed to thalidomide, and the drug was removed from the market in most places. Many countries took this crisis very seriously and subsequently reviewed and revised their regulations surrounding pharmaceuticals and clinical trials. Something most people may not know is that in 1977, the FDA released a recommendation called “General Considerations for the Clinical Evaluation of Drugs” that more or less prevented women of “childbearing potential” from participating in phase I and II clinical trials because of the “risk of pregnancy” and subsequent risk of harm to a fetus.

 

While this action was intended to safeguard human subjects, the result was that women were largely excluded from clinical research for the next few decades. In grad school, we were taught that women have been left out of research because menstrual hormones contribute to the variability of health outcomes, which is also true to an extent. Attitudes towards the inclusion of women may have also been subject to underlying social discrimination. Whatever the reason, the bottom line is that women can’t and should not be left out of research. It’s as simple as this: if research findings are to be extrapolated to females, they must be actually measured in females. Females have different pharmacokinetics, dosage requirements, and even adverse events, and male data cannot be used to predict this important female data.

 

And then the pendulum swung. In 1988 and in the years thereafter, many different initiatives began to advocate for the inclusion of women in clinical research. The NIH established the Office of Research on Women’s Health, and the Department of Health and Human Services followed suit with their own Office of Women’s Health. Bernadine Healy was appointed director of the NIH and immediately launched the Women’s Health Initiative, which resulted in several huge epidemiological studies of women’s health outcomes. Legislation changed the course of research guidance, mandating that the FDA establish an Office of Women’s Health and related guidance for industry. Attitudes have also begun to change; peer-review journals and federal funding agencies began to require justification if studies did not include both males and females. These were all important movements, on principle.

 

But have these initiatives changed anything? A very detailed history of analyses covering women’s inclusion in clinical trials has been published. Surprisingly, women seemed to be well represented in the 90’s and early 2000’s for the most part, but a more recent study of trials conducted between 1994 and 2009 showed that females accounted for only 37% of participants and that 64% of trials did not report on differences of treatment by sex, which was made part of the FDA guidance in 1988. What’s worse is that out of the 56 studies, only 3 acknowledged the limited generalizability due to lack of diversity in the study population, based on both sex/gender and race. It’s also been said that therapeutic areas that pertain only to women, such as cervical cancer or endometriosis, can be undervalued and underfunded.

 

Many reasons have been proposed to explain the continued disparity but there is no concrete answer. Recruitment strategies may not be thoughtful enough, and a general awareness of research may be lacking in women. If females are caregivers of young children, they may not be able to take time away from home to go to study visits. A great suggestion was offered to collect feedback from women at the end of trials to guide future recruitment efforts.

 

Researchers: remember to power your sample sizes to be able to detect any sex differences in trial outcomes. Sex differences in safety and efficacy are considered so important that the FDA’s Office of Women’s Health continues to guide research efforts to better detect them. Also, be sure to report measures of variability for both sexes so that future trials may be better informed, since variability of an outcome can be higher in one sex than in another – and by the way, it’s not always higher in females. Finally, if there are plans to submit clinical trial data to the FDA, guidance for NDAs reiterates that the FDA requires information based on subgroup analyses, which need to include sex and/or gender. While it may increase the budget to include more participants to account for these factors, remember too that likely half of your customers will be women.

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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