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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

    • Clinical Services
      • 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.

    • 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

Architecting Solutions Today for the Challenges of Tomorrow

Biorasi is widely recognized as an expert in complex trials, as a trusted resource for trial rescue, and as a pioneer in cutting edge clinical trial methods such as big-data enabled risk-based monitoring.

Over the last two decades, Biorasi has worked with some of the leading names and most innovative life sciences startups in pharmaceuticals to improve clinical trial outcomes for sponsor partners, and for patients.

Our growth has happened because of our strong commitment to building true partnerships with our sponsors, as well as our commitment to moving the industry forward through better project management, better processes, better technology, and better people.

Exceeding CRO Industry Standards

Biorasi provides our global pharmaceutical sponsors with innovative, customized solutions, consistently delivering, highly successful, complex clinical trials, allowing faster trial completion while minimizing their risk of failure.

Biorasi designs and executes trials around the unique needs of each of our sponsors, providing a unique trial management model, unifying teams and their processes with a proven methodology and technology, leveraged on our TALOS™ Ecosystem.

Our mission at Biorasi is to ensure you with highest-quality, optimized clinical trials that accelerates drugs or devices to market while exceeding industry performance standards. Our process and approach is exemplified by our growth with salvaging distressed trials.

Exceeding Industry Standards

Feasibility

Site performance isn’t limited to a database of patients or the time an investigator has been in business. Historical recruiting, communication times, responsiveness, and leveraging business intelligence in our TALOS Ecosystem provide the most realistic model for recruitment.

Protocol Finalized to First Site Selection Visit
Biorasi
5 Days
Industry Standard
14 Days

Site Selection

Logistics for SSVs are pre-planned and first site selection visits (SSV) occur within 48 hours of obtaining the finalized protocol. Biorasi works with sites and partners during feasibility and protocol development to ensure rapid deployment.  
 
Site Selection Visit to Site Initiation Visit
Biorasi
28 Days
Industry Standard
90 Days

Site Initiation

Site terms and contracting are established during the selection process. As the site is selected Biorasi schedules a site initiation visit (SIV) within a month of the SSV, however getting a site operational within three days of the SIV is closer to our norm.  
 
Site initiation Visit to First Subject In
Biorasi
3 Days
Industry Standard
21 Days

MISSING A KEY MILESTONE?

Biorasi is recognized as a leading expert in delivering success where other CROs fail

Bringing trials back on track is a forte of Biorasi, picking up where other CROs falter. Our rescue services provide solutions to help even the most challenging trials meet their goals. Biorasi is recognized as a leading expert in delivering success where other CROs fail.

Biorasi is the “Go To” resource for distressed Trial Rescues.

Navigating Complex Trials for Faster Approvals

Biorasi’s methodology leverages our TALOS Ecosystem, an integrated technology and program management platform designed exclusively for Clinical Research. The efficiency of the TALOS Ecosystem offers greater success
for our sponsors and allows faster trial completion while minimizing risk of failure.

“One of the rarest events, where we had to communicate with Biorasi to stop the screening rather than boost it.”

VP of Global Clinical Development, Top Specialty Pharma

Latest News

Biorasi is 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.

CONTACT INFORMATION

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