• 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

Last week, one of our resident experts in ophthalmology, Ignacio Handal, gave a training for some of our current studies with a focus on which pitfalls to avoid specifically in ophthalmology trials. He dished out many fun facts and eye-opening insights.


Compliance is difficult enough to achieve for any medication, and remembering to take eye drops on top of oral medications is an easily forgettable extra step. Only half of glaucoma patients are compliant with treatment regimens, and that proportion falls further as the number of other prescribed medications increases. Eye drops are also uncomfortable (who wants to hold their eye open while they pour in a foreign liquid?). They can also be annoying and troublesome to administer, if the method is to try to hold the bottle steady while dangling it over your eye, especially if tremors are involved. But something many people don’t know is that the bottles are designed to rest on the bridge of your nose! This way, hand-eye coordination is less of an issue, and you sure don’t want to miss. Some of these eye drop medications are upwards of $600 per tiny bottle.


Because vision is the relevant outcome in many ophthalmology studies, study assessments largely rely on patient-reported, and quite subjective, data. An example is the Humphrey test to measure visual field. In this exam, patients focus or fixate their gaze on a central light and then report whether they can see lights flashing in their peripheral field of view. The basic version takes about 10-15 minutes per eye, with longer versions taking up to 30 minutes per eye. Needless to say, this is exhausting for patients. In Handal’s experience, some patients will give great effort, and some will not. The biggest problem lies in inconsistency of effort: if patients give 100% effort the first time, and then taper off over time, it will look like they are losing vision over time, which is very problematic for studies measuring vision loss. Fortunately, there is a way to monitor how “compliant” patients are with the exam: their fixation can be measured with a small camera that captures eye movement. This at least allows physicians to determine whether the data is reliable or not. For this, though, Handal recommends telling the patient to give consistent effort, even if it is not 100% every time, so that significant reductions in overall vision can be tracked.


There can also be troubles with assessments that are done by the physician, according to Handal. “You have to have good vision just to be an ophthalmologist.” Doctors don’t have an amazing view of the back of the eye; it’s a pretty blurry picture. This can complicate assessments and reduce the reliability of trial data.


The order of assessments matters too. Assessing hyperemia in the eyes (eye redness) after a patient has had their eye poked 8 times to measure cornea thickness via pachymetry is not a good idea. Simple solution: always do non-contact exams first!


Screening and baseline measurements are also of paramount importance and should be done cautiously. If screening is lax and patients with worse vision are accidentally included in a trial when they shouldn’t be, then events found during the study that are actually historical findings are wrongly reported as adverse events, and the patient can also personally be at a higher risk of harm from the experimental treatment. If patients are screened more conservatively, there will likely be fewer adverse events during the study.


The benefits of working so diligently to run successful ophthalmology trials are apparent in some recent advances. In the training, Handal told us about a newly approved gene therapy for hereditary retinal dystrophy. Handal feels especially sad for these patients, since the disease manifests in early adolescence and can result in complete blindness by mid-twenties. These children once knew the beauty of the world, and it is taken from them early in life. Not surprisingly, patients with retinal diseases have one of the highest incidences of comorbid depression. But advances like these are changing the game for these patients who were previously orphaned by pharmaceutical companies because of the rarity of the disease.


Interestingly, this was actually the first FDA-approved gene therapy targeting a disease resulting from a genetic mutation. When we think of gene therapy, this is what most people probably imagine: an engineered, normal copy of a gene traveling to the location where a defective gene is expressed and replacing it, restoring normal function. This is exactly what is happening with Luxturna, but it’s not the way most gene therapies work in practice.


Handal and other experts in the field are working hard to run successful trials in ophthalmology. The advances made thus far are truly amazing, considering that people who once could not see are seeing the world again, and there are many more innovations in the works.


Meet our Subject Matter Expert:

Ignacio Handal studied microbiology and biomedical sciences at Auburn University in Alabama. Prior to joining the team at Biorasi, Handal was the Director of Clinical Research at Eye Center South, which is the 5th largest ophthalmology practice in the country. He started the research division there himself and was managing around 10 pharmaceutical studies at any given point. Now the Director of Program Management at Biorasi, Handal bridges our Program Development and Project Management teams so that sponsors experience continuity of care from project conception to close.

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