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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

When recruiting patients with hard-to-enroll indications, such as rare diseases, it is sometimes necessary to dip into creative resources for finding sites. Sometimes this means looking across the ocean, or sometimes there may be opportunities in your backyard. Some sites have a lot of experience, and those are generally sought after, but they can be busy running other trials and may not prioritize yours. It may be beneficial to include less experienced sites in order to have better chances of enrolling. But of course, there are some necessary considerations when turning to these sites.

 

Pros of using research-naïve sites

  • Depending on the method and amount of startup funding the investigator has, new sites may have newer equipment, which could be very beneficial if the trial relies on certain instruments for study assessments.
  • New sites may be running few to no other trials concurrently; other trials can compete for the same patient population, especially if the site physician or principal investigator (PI) is a specialist.
  • Some of the sites that are newer to research may be more gung-ho about getting involved in research, and motivating the study team to enroll may not be much of an issue at all.
  • New sites don’t have a track record of audit violations, and as such, they may be more inclined to carefully follow the rules and keep their record clean, especially if they believe they are under tighter scrutiny.

 

Cons of using research-naïve sites

  • Depending on the background of the PI, new sites may need lots of training. The vast amounts of training required for starting up sites may be overwhelming to the site staff, especially if they are still finding their rhythm. Sponsors need to select CRO partners who have a long history of training investigators, who are knowledgeable in both the therapeutic area and in training methodology, and who are proactive and urgent in other matters such as project planning or protocol amendment coordination.
  • New sites may not know for certain how many potential patients they can recruit, and they may be overzealous in estimating their enrollment rates during the feasibility process. One solution is to assume that their rate will be a little lower than expected, and anything higher than that will be a pleasant surprise.
  • Along the same lines as audit violations, new sites don’t yet have a track record of successes, either. It can feel risky to choose a site that has a shorter history to evaluate.

 

Other considerations

  • Just because a site is research-naïve doesn’t mean the PI is. When choosing a site, it’s important to look into the individual PI’s experience and audit records.
  • “New” sites may not actually be new; they may just be operating under a new name. Whether the name change was benign or not is not always clear, so some deeper digging may be required to find out if a name change was enacted to dispel a bad reputation.
  • At Biorasi, our project managers do not outright reject sites that have the patient population but lack adequate human resources to support the trial. If the patient population is proven available, we instead support such sites personally to build up their capacity so that they can successfully recruit the targeted patient population.

 

All sites were new at some point. Someone took a chance with them, and that chance has paid off in many instances. Having a mixture of experienced and not-so-experienced sites can also be beneficial in the same sense as diversifying financial assets is desirable, just in case there are certain characteristics that predict success that have not yet been identified. Careful monitoring is, of course, paramount to make sure that sites, old or new, are carefully recording trial data and handling adverse events.

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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