• 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

In research, anytime variation is introduced and unaccounted for, it can mask the true results of an intervention. Variation can come from seasons, meaning that clinical trials should be accounting for this. The summer season can contribute to variation and can introduce other specific challenges to a clinical trial. Some of these challenges may also appear during the winter months, and fortunately, the same solutions apply.

We humans are different creatures in the summertime. We eat differently, we exercise more (or less) than during other parts of the year, and we spend more time outdoors. Changes in our biochemistry can result. In a clinical study, all of these differences can turn into confounding factors, or factors that are actually responsible for differences in study results that falsely appear to be due to the treatment or intervention. For example, vitamin D, which is produced in the body during sun exposure, is generally found in higher concentrations in the blood during the summer. Vitamin D acts as a hormone that influences many different physiological processes. Cholesterol can also change with the seasons. With any biomarker or clinical endpoint that varies by season, if some participants are enrolled during the summer while others are enrolled during the winter, this can contribute to undesirable variation in baseline data or differential responses to treatment. Medical events also occur more frequently in some seasons compared with others; this can directly impact study results.

There are also logistical challenges to running a trial during the summer months. The many holidays and ensuing vacations during the summer months can slow and delay communication between sponsors, investigators, and participants. This in turn can result in missed milestones. Multinational studies may also experience additional holidays from other countries. Some participants report that the summer season can negatively affect their compliance with a treatment, and it is not necessarily because of vacations. Separately, going on vacation can also affect compliance, and being away from home means that participants must take care to store their medication appropriately (i.e. refrigeration). In patients with chronic diseases who are hospitalized, the length of hospital stay can be longer in the summer.


There are ways to combat these added challenges when running a clinical trial. Most of these solutions must be implemented during the planning stages of a study, but there are often creative solutions for rescuing a trial failing for seasonal reasons.

  • Plan ahead. Be sure to design meetings, conference calls, site visits, and participant study visits around all possible holidays, considering national holidays of all involved countries and allowing extra time for things to get done during popular vacation months. Use data from study sites to predict how participant compliance may be affected during certain months at certain sites.


  • Screen more strictly. If sun exposure is going to directly interfere with an intervention, such as in a dermatological study, it may be a good idea to exclude people who spend a lot of time outdoors. This data can be collected at a screening appointment and used to determine eligibility. To ensure better rates of compliance, some studies employ a run-in period prior to randomization with the sole purpose of making sure participants will complete their assigned study activities.


  • Enroll more participants and account for these factors statistically. If it is not justifiable to exclude participants based on factors that will interfere with study results, it may be best to enroll more participants to be able to run adequately powered subgroup analyses. Similarly, if a low level of compliance is expected or even detected during the study, more participants can be enrolled to compensate. As a last resort and with appropriate FDA and/or IRB approval, sample sizes can be increased after a trial has already begun.

Download a Sample Rescue Trial Report

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