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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

It’s pretty common for a pharmaceutical company to have a list of demands ready when choosing a CRO partner for a clinical trial. Here at Biorasi, we have some demands of our own that we consider non-negotiable and vital to the success of any trial. This isn’t because we’re divas that come with a rider. It’s because without some key commitments from the sponsor, study success is far from guaranteed. These non-negotiables help to ensure that sponsor and CRO move in concert to achieve a clear and well-defined goal – moving your clinical development program in the right direction.

 

  1. Be available for both planned and unplanned communication.

Because communication between sponsor and CRO is so important, we develop an entire communication plan prior to the start of the study. This includes several one-time meetings (kick-off meeting, boot camp, and investigator meeting) and frequent, ongoing conference calls (at best weekly, or sometimes monthly); frequent, regular meetings are an important aspect of teamwork. Additionally, the best results occur when a sponsor is consistently available for unplanned communication. Very often, quick turnaround is required for amendments to plans, resolutions for protocol ambiguities, and decisions about vendors; when the sponsor is not responsive, the timeline of the study can be affected. Good communication may be best achieved when there is a single, consistent representative from the sponsor who is always available to interact with the project manager from Biorasi.

 

  1. Handle FDA interactions.

The sponsor facilitates all regulatory approvals, such as the IND, for the clinical trial and any other communication with the FDA. It is very important for the sponsor to share the latest updates with their CRO in order to make sure the trial is fully compliant with all FDA directives and instructions. Failure to do so can be catastrophic for a drug development program.

 

  1. Review study documents carefully.

The sponsor should thoroughly review the study plans (communication plan, global project specification plan, monitoring plan, safety monitoring plan, data management plan, data validation plan, statistical analysis plan). Ideally, most of these should be completed and approved before the first participant is enrolled, since changing plans mid-course is significantly more difficult and can lead to serious delays or deviations.

 

  1. Manage sponsor-selected vendors.

The sponsor will oversee any vendors that are sponsor-selected. Part of Biorasi’s service to the sponsor includes selection and acquisition of vendors; however, it is not uncommon for sponsors to have preferences for certain vendors to use during the study. If that is the case, the sponsor undertakes responsibility for communication with the vendor and management of that relationship.

 

  1. Prepare for changes to the study budget.

Our budget is designed to be as accurate as possible from the beginning. However, unforeseeable changes can occur during the course of the study, including the addition of new vendors, protocol amendments, or additional site visits that can increase the cost of a study. The sponsor must acknowledge that some actions will lead to a change order that alters the original budget. Budget amendments are always at the discretion of the sponsor, and Biorasi works hard to negotiate with vendors to minimize costs. However, if necessary budget amendments are repeatedly rejected by the sponsor, the study can stall.

 

  1. Be GCP-compliant and audit-ready at all times.

All parties, including the sponsor, need to be GCP-compliant and audit-ready at all times. Biorasi’s CRAs keep tabs on site activities through frequent conversations with investigators and routine site visits. Biorasi monitors sites, the sponsor audits the sites and Biorasi, and the FDA audits all of us. This places the sponsor second to the FDA in terms of responsibility.

 

  1. Allow reasonable time for quality.

Sponsors should allow us an appropriate amount of time to deliver a quality product. This includes documents, monitoring visits, reports, etc. We work with sponsors to build timelines that are fast and thorough, but certain things cannot be delivered yesterday. If there are concerns about timelines, a conversation with a project director or manager can usually identify ways to shave some time and will result in better outcomes compared with trying to rush a process that shouldn’t be rushed.

 

  1. Keep to the study timeline.

Sponsors should make a good effort to keep to the study timeline, as everyone at Biorasi does. No one is above procrastination; it happens from time to time. Proper planning prevents poor performance, and a lot of delays can be avoided by responding to requests in a timely manner.

 

In exchange for these expectations, Biorasi promises to be transparent, professional, and vigilant alongside sponsors. Although part of the job of a CRO is to assume responsibility of the study, the sponsor holds the ultimate responsibility for a clinical trial, and it is very important for them to find the right CRO to share in this responsibility.

Our team members are invested in every study we run for our sponsors, since we equally desire success. Even so, it’s important to remember that a clinical trial is a team effort, and the sponsor is a vital part of that team. Following these guidelines, either with us or with any CRO, will help sponsors to make sure that their clinical trial has the best chance of success.

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