MENUMENU
  • 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
    • 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.

    • 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.

    • Clinical
      • 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.

    • Regulatory
      • 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 Sciences
      • 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.

    • 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

  • Therapeutic Areas
    • Dermatology
      • Dermatology

        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.

    • 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.

    • 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

When people think about women’s health, especially during the month of October, they may think only of breast cancer or reproductive disorders. The truth, though, is that women’s health encompasses so much more. The field of medicine pertaining to women’s health is rapidly growing to include the study of both specific conditions that only manifest in women and also maintenance of well-being and quality of life during the unique but normal life cycles experienced by women. Fortunately, we are beginning to understand the implications of women-specific needs on mental and emotional health, and new devices are being designed to cater to these needs.

 

One of our goals in writing this article was to push back on some of the stigma surrounding women’s health. If discussions of reproductive health upset you, this may not be the article for you. However, it’s important to move past this discomfort if we really plan on bettering the lives of patients that make up more than half of the world’s population – women.

 

  • Ava is an FDA-registered bracelet that tracks ovulation and fertility. The fertile window is defined as the 5 days leading up to ovulation and the day of ovulation, and ovulation has traditionally been determined by counting 14 days backwards from when you expect your next period to start (or by measuring hormones in the blood at the doctor, but that’s not feasible to do every day). What happens if you don’t know exactly when your next period will be? Or, as is the case for many women, what if your cycle length varies slightly each month? Conveniently, markers such as skin temperature and pulse rate during sleep have been validated against urine tests to predict when the body is about to ovulate. This bracelet doesn’t only track fertility, though. It also tracks sleep habits, stress levels, and symptoms related to the menstrual cycle with the goal being for women to learn more about their bodies and improve their habits.

 

  • Portable, silent, wearable breast pumps are a revolutionary invention for women who are breastfeeding. Most of us are aware of the stigma surrounding breastfeeding, and some employers have begun to show support by providing lactation rooms at the office, at the very least. Not everyone recognizes the importance of supporting a mom’s breastfeeding needs, though. It can be embarrassing to carry around a breast pump and to take long, frequent “bathroom” breaks. The portable, wearable breast pumps made by Willow or Elvie can be worn under normal clothing, not only freeing women’s hands to continue working while pumping but allowing her to inconspicuously remain at her desk as if nothing is different. As an added benefit, for those moms who are worried about whether their baby is eating enough, the device also makes it easy to measure the amount of milk a baby is consuming.

 

  • In the same vein of measuring a baby’s milk consumption, MomSense manufactures a device that senses the mouth movement of a baby, able to distinguish between small gurgles, half-gulps, and full gulps and the related volume of milk consumed. The data collected from the sensor transmits to an app on your phone, easily logging breastfeeding sessions. Moms can also listen to their babies’ rhythms for a potentially better bonding experience.

 

  • We all love our Kegels! While this may be a laughable matter to some, these types of pelvic floor exercises are extremely important for women recovering from labor and delivery in regaining bladder and bowel control. The Elvie Trainer provides reminders to complete the exercises and can show you the strength of your contractions with all data transmitting to an app on your phone.

 

Bear in mind that all of these wearable devices are clever sources of data. Data collected by these devices may provide important information for clinical research. Value can be found in the vast amounts of data on daily habits, which would allow for the design of more patient-centric protocols that better accommodate women’s needs. Value can also lie in the collection and identification of potential confounding factors on women’s health outcomes; hypothetically speaking, if sleep habits were observed in device-derived data to vary by age, and a new sleep medication is being evaluated in women of all ages, it may be prudent to run a subgroup analysis on sleep outcomes based on age. The possibilities for putting these data to work are endless.

Got a question?

We have Experts available to answer your questions
Complete the form on the right or give us a call.

Biorasi is a full-service, global CRO whose vision is a future where data, process, and technology work together seamlessly to accelerate drug development for the benefit of our sponsors and their patients’ lives.

We are 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.

© Copyright 2019 Biorasi, LLC. All rights reserved.  |  +1 786-383-0454

Download a Sample Rescue Trial Report

Please provide your email address so we can email your sample rescue trial report.