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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

Many clinical trials are initiated by a pharmaceutical company in order to generate data to submit to the FDA for drug approval. Investigator-initiated trials (IITs), on the other hand, are conceived by a clinician and not by the company that plans to sell the drug or device under study. IITs present a way for post-marketing, real-world data to be added to a drug or device’s portfolio without the sponsor initiating the research. IITs can also identify new uses and indications for drugs and devices, whether they are already approved or are still pre-market.

Everyone can agree on the fact that more research, and especially real world evidence, is helpful for advancing the field of medicine, but not everyone is always in favor of IITs.

 

Here’s the problem: many sponsors have trouble justifying funding for a trial that doesn’t fit into their “strategic interest” pipeline. To be fair, companies have corporate plans and expectations from stakeholders, and funds are generally allocated based on these pre-defined plans. On top of that, IITs may reveal new safety concerns of a drug or device that were not discovered during pre-market studies, producing risks in which business outcomes are difficult to predict.

 

But there are some good reasons for sponsors to support IITs that may outweigh this risk. Dr. Viraj Suvarna, MD, MS, previous medical director at Boehringer Ingelheim, previous head of medical operations at Pfizer, and now independent healthcare consultant, raises a great point: “Such studies can be conducted by investigators independent of any company funding. So, the company’s assets, including rights to the data, could then be at risk and it is better if the sponsor and investigator can mutually agree upon monitoring duties and regulatory approval strategies.” If the sponsor has no oversight or monitoring capabilities, they have less opportunity to protect their assets, and they also may miss out on the chance to gain any intellectual property resulting from the research. Another reason for sponsors to support IITs is that the sponsor may appear less than responsible if new adverse events surface in post-marketing studies that they were not involved in. It’s fair to acknowledge that there is a risk in finding out that your product does more harm than good, but working collaboratively with IITs can give companies the advanced warning they need to address the issues before they become public and spiral out of control. No one wants to deal with another Vioxx situation.

 

Dr. Suvarna has written a few editorials on the topic and has also pointed out an important ethical consideration. Many clinical trials are conducted in India in order to reach enrollment requirements. The sites in India have investigators, and these investigators are very capable of contributing to the trial’s protocol development. By the time the sites are involved though, the protocol has already been finalized. Physicians in India therefore do not get the chance to contribute to the protocols to provide their real-world insight. Unmet needs of patients in India can be different from unmet needs in other countries. IITs would be a great opportunity to improve this situation, but they are not happening. Whether this is because investigators are not applying for funding from sponsors or because they are denied sponsor funding is not well known, since companies are understandably not keen on disclosing these data about how many proposals they review and approve.

The best-case scenario for a sponsor who funds an IIT is that new indications will be discovered for the same drug that is already approved, and this can substantially advance drug sales.

 

CROs can play an important role in carrying out the sponsor’s monitoring duties. A reminder to investigators: a sponsor, in selecting a CRO to help with an IIT, is simply acting out of due diligence to ensure that their product is being appropriately accounted for. They are under regulatory scrutiny anytime they sponsor a study involving their product. They may want to hire regulatory experts to help with the research efforts because they will have to answer to the FDA later on. A sponsor may also request that their SOPs be used to conduct the trial so that the data can be submitted to the FDA. This is less of a powerplay and more of a regulatory necessity.

 

For a final word on “competing interests” – an investigator’s desire to further the field versus a sponsor’s desire to promote a product – here’s an alternative perspective. A sponsor’s interest and a patient’s interest are more closely tied than some may think. A sponsor can only invest in the laborious, expensive, high-risk effort to develop a drug if it will sell. The product will only sell if it really helps patients (and if the patients themselves like taking it; otherwise, they won’t take it). IITs allow for a collaborative effort in which the investigator, who sees patients and is in touch with the real world, is involved in the protocol design. The research may then be more meaningful and come out to benefit the drug’s value in the long term.

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