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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
    • 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
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Clinical research in dermatology has a reputation for being simple and easy to conduct compared to other therapeutic areas. Developing therapies for the largest organ in the human body is not an easy task. For starters, dermatological conditions represent one of the most common health problems in the United States with an estimated one third of Americans suffering from at least one skin condition. Each year nearly 85 million Americans visit a physician for at least one skin disorder, costing the U.S. healthcare system over $90 billion annually. Also, it is true that trials don’t always have the morbidity, complex study design, or rarity factors of other indications, however the myth that dermatology studies are simple isn’t exactly accurate. There are a number of specific challenges that affect dermatology alone and here we will present some reasons why there is more to these studies than meets the eye.

 

Roadblocks to Recruitment
One of the most unique challenges to recruitment for dermatology trials is something many of us can’t avoid, the sun. This is because many skin conditions and their treatments depend on getting just the right amount of UV exposure. Environmental restrictions are present in many other therapeutic areas, however few are quite as difficult to work around as strict limits for sun exposure and no other therapeutic area encounters such frequent environmental restrictions in study design. Recruiting patients in May for a three month trial requiring limited sun exposure anywhere south of the Mason-Dixon line can be nearly impossible.

The solution to this challenge lies in the implementation of strategic recruitment tactics and the best tactics vary from trial to trial. In south Florida, we are very familiar with the sun and the challenges it presents to clinical research. Sites can be identified and selected utilizing algorithms that account for selected variables such as ambient sunlight. Variables can further be reduced by providing sunscreen free of charge to sites in sunny places. In addition to tactful recruitment strategies, big data can be leveraged to increase the speed and accuracy of patient recruitment and cohort generation by tapping into data from historical clinical trials offering early insight and reducing failure rates.

 

Retention Strategies are the Key
The average patient drop-out rate in clinical trials is estimated to be around 18% with dermatology trials being higher due to a number of factors including lack of proper education, concurrent use of over the counter skin products and the presence of disproportionately large adolescent population. This is specifically seen with acne trials and many clinical trial protocols require strict adherence to rigorous regimens to prove safety and efficacy, however getting younger participants to follow complicated protocol procedures can be a daunting task.

Teenagers are not known for being compliant, especially when it comes to following directions and being punctual. This presents a problem for investigators seeking to generate quality data and bring new therapies to market. In a recent trial in jeopardy of failing due to drop outs, the study was rescued by providing gift bags and information pamphlets explaining the study.  Integrated technology platforms, such as mobile apps built on an EDC system, not only provide quality education, they enable researchers to push data back to patients for ongoing feedback and communications. The introduction of mobile health tools is encouraging more patient-centric research practices—alleviating patient burden and improving compliance and retention.

 

A Not So Simple Solution
Skin isn’t so simple after all and dermatology trials pose some unique challenges that require the attention of an experienced study team. With so many factors affecting the success of a trial, designing and conducting dermatology trials can be tricky. Enhanced training for patients and investigators may be sufficient for some trials while others may need a complete change in study design. The integration of new data sources and innovations in mobile health are already streamlining manual, resource-intensive processes leading to accelerated timelines and achievement of key milestones.

Through effective education and optimization of data-driven insights, the barriers to recruitment and sustained enrollment in dermatological trials can be conquered. Over a decade of experience conducting dermatology clinical trials has given us insight on historical metrics by integrating new data sources, leveraging machine learning and deploying data science solutions into the clinic ultimately increasing the success rate of dermatology trials and helping to improve patients’ lives.

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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.

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