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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
    • 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

    • 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

The study is behind schedule. Enrollment is lagging. The protocol is too complicated. Approximately 80 percent of all clinical studies need intervention or optimization to be successful, but only about 10 percent get it. Why? Because there is an negative connotation to the term “trial rescue.” Some Sponsors don’t want to admit their clinical trial needs assistance — and some contract research organizations (CROs) don’t want to request help.

In reality, receiving clinical trial assistance as soon as trouble rears its head is the best way to save time, resources, and cost. At Biorasi, we are experts at trial rescues — working with Sponsors and CROs to help identify and correct the inefficiencies or issues that are keeping the clinical trial from reaching its full potential.

Trial rescues are common, important, and transformative. Here are the top four reasons Sponsors need help to ensure their clinical trial is as productive as possible.

Reason: Planning

Ineffective planning is the number one reason why a clinical trial can get off course. Maybe stakeholders disrupt the planning process. Perhaps there are enrollment problems that could have been foreseen and avoided if the planning had been more rigorous. Whatever issues arise, we leverage a diagnostic root cause gap analysis to shed light on holes in the planning — and find the best ways to mitigate future issues. Project management is critical to any clinical trial; making sure everything is managed against a solid plan provides the best chance for staying on track.

No clinical trial is perfect and no two clinical trials are the same, which is why there is always the potential for something to go wrong. Our team plans for any and every risk to ensure that the safety nets are in place when and where they should be so that the trial stays on track. Let’s say a Sponsor is rejecting site after site because each lacks one out of 10 criteria needed for the study. Our team might recommend that instead of spending more time and resources looking for “the perfect sites,” the Sponsor fix those criteria so the sites can participate. By doing what we can to logistically plan for the trial, we can help the Sponsor keep up with timelines and milestones.

Reason: Enrollment

Enrollment issues can delay the clinical trial, create a longer timeline, and increase cost. According to a national opinion poll, 72 percent of people are willing to participate in a clinical trial if they are asked. So how do Sponsors reach them? The answer may not always be more sites: adding study sites doesn’t linearly increase recruitment rates. Having relationships with many organizations and clinics is one component to finding patients, but it’s also about selecting the right sites. It is important to match sites to patients. Biorasi has global affiliations that enable swift ramp up and access to various patient populations.

Reason: Unnecessary Protocol Complexities

Increased protocol complexity inflates clinical trial time and expense. By leveraging the gap analysis tool, our team can review the protocol to see if there are ways to improve the design of the study. If we discover opportunities to do so, our study design and statistics group works with the Sponsor to realize those changes. While the study protocol is second nature to the Sponsor, working with a third party can often uncover design enhancements or modifications that were initially missed.

Reason: Circumstances Beyond Your Control

Many outside influences — regulatory or manufacturing issues — can affect a clinical trial. Things can go wrong with formulations; patients can decide not to comply. There are always challenges and, while it’s impossible to design a foolproof protocol, bringing in the right team that can come up with solutions effectively is key to moving past the issue.

Sponsors rely on Biorasi for trial rescues because our team is swift, agile, flexible, and solution-driven. We can provide an optimization road map for the Sponsor to use or work side by side with the incumbent CRO to deliver results. And in the event the Sponsor asks us to take over the study, we are sensitive to the transition.

To learn more about Biorasi’s expertise in trial rescues click here.

Download a Sample Rescue Trial Report

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