• 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

Authors: Geetesh Shrivastava, Associate Director of Clinical Monitoring; Jennifer Dennis-Wall, PhD, Lead Scientific Writer

Back in August, we published a blog addressing themes that are important for sponsor partners to follow so that we as a CRO can provide them with the best possible service. To complement those themes, we looked inward and did some digging on what makes our teams here so successful, especially when we are faced with surprises that inevitably pop up during the course of a clinical trial.


A team is only as successful as its leadership, and leading successfully and gracefully is both an art and a science; a title does not make a manager. Here are some of the qualities a strong manager will have:

  • It is the easiest thing in the world to jump to a conclusion or form an assumption without finding out all of the facts. Really listen to your team members. Ask them questions, and be open-minded to taking their point of view. Listening is something all of us can do more often.


  • Trust your team. If you don’t trust them when you hire them, then at what point will you surrender the control? More importantly, when a team member feels trusted, they will naturally feel more accountable and responsible for the job they are entrusted to do. Conversely, if they know that all of their work will be redundantly checked over, then why would they bother being careful? Give your team some flexibility to get the job done, and they will feel trusted.


  • Treat each member of the team as an individual. Understand how each member of the team functions differently. Some people are fast and thorough but don’t like to be interrupted while some prefer to receive constant reminders and updates. Some like to talk about their emotions, and some don’t. As the manager or supervisor, you are the one who understands the big picture and can tweak operations to be more efficient based on individual needs and strengths.


  • Understand the disconnect that leads to an escalation. This means seeking to understand all points of view. Look inward before assuming that the blame lies with someone else. Did the team member receive clear, complete instructions and expectations? Was the training for this team member adequate?


  • Be a servant leader. This means working with the team, rather than trying to control them. While it’s important not to get into the trenches too much so that you can maintain your well-oiled machine, team members really respect someone who has done the job themselves and isn’t afraid to get their hands dirty.


  • Delegate unexpected tasks swiftly and with clear instructions and expectations. This is a skill that comes with practice. We all know what if feels like to be swamped with too much work, but when you are a manager also doing work that could be delegated, this is a waste of resources and a recipe for failure. Be acutely aware of when a task could be delegated, and don’t be afraid to let someone else do it a little differently than you would do it. The more important thing is that it gets done so that the whole project can move forward.


  • Hold frequent team meetings. Keeping everyone in the loop makes them feel important and helps them to understand the big picture the team is working towards. Some team members are more open about sharing the status of their tasks with their supervisors, and some are not as open. It is perfectly fine to hold additional one-on-one meetings as well with individuals who are not as keen on sharing.


  • Maintain an open, transparent dialogue with the team. Most often, when a team member knows about the uncomfortable stuff that you are dealing with as a manager, they will feel more empathetic towards you. In doing so, they may offer to take some things off your plate, and you may consider accepting those offers if it frees you up to manage and direct. Also, openness and transparency commands respect; people respect a leader who gives direct feedback (especially if it’s uncomfortable) and who admits their own weaknesses.


  • Be gracious when deviations occur. The majority of workers put enough pressure on themselves to do a good job and punish themselves when they make a mistake (not that this is a behavior we endorse). If they receive harsh treatment from their supervisors as well when they make mistakes, they may either feel less secure in being able to complete their tasks, breeding more mistakes, or they may resort to hiding future mistakes, which can be disastrous for a clinical trial.


  • Recognize the capability and availability of each of your team members. Learning your team members’ individual strengths and weaknesses should be a priority so that you can delegate tasks to match personalities and abilities. Team meetings and one-on-one meetings help tremendously in surveying how busy each member is at any point. You don’t want to overload your strongest team members. If someone offers to do a job that they haven’t done before, give them a chance; worst case, they don’t deliver, and you clean up a bit, but there is a good chance that they will deliver.


Most of these themes all boil down to good communication, which can be learned, fortunately. Listening and seeking to understand are important skills that require surrendering pride and control, which can be easier said than done. A good leader is respected when he or she sets a tone of respect with their team members. At Biorasi, we focus constant attention on making sure these themes are woven into our operations and culture, and this is one of the factors that allows us to attain some of our unlikeliest timelines.

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