MENUMENU
  • 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

Some physicians are reluctant to participate in clinical trials as a referring physician. This is a huge issue because a large portion of participants can come directly from a referring physician’s office.

Referring physicians hesitate to get involved in research for several reasons. One of the main reasons is that they may be afraid they will lose their patients to the investigator physician who will be giving them medical attention during the study. Many physicians who are not regularly involved in clinical research don’t fully understand the importance of the specific research being done and therefore don’t care to promote it (similar to any other member of the research team). Finally, referring physicians, especially PCPs, do not have clinical research on their radar; general awareness of research is lacking because it does not command their attention as much as their other tasks.

Seeking solutions for these issues, we spoke with Christina Norris, VP of Clinical Operations at Benchworks and specialist in planning, developing and executing patient recruitment programs for clinical trials.

 

Easing Fears

To quell any fears of losing patients, Norris says that PI’s need to leverage existing relationships and create a level of trust with their peers in healthcare. “Referring physicians can have a large impact on patient enrollment, and we [investigators] must ensue trust and a sense of camaraderie to eliminate any fears a referring physician may have about losing their patients if they refer them into a clinical trial.”

PI’s also need to make sure the research participants know that they should continue seeing their PCP even during the study. “Investigators hold the responsibility of making sure patients know that they are getting additional care while in the study, not replacement care.”

 

Explaining the Why

Understanding the end goal is also quite important in this situation, Norris says. It’s easy to get overly wrapped up in the business or academic nature of clinical trials. Many physicians can forget that the ultimate goal of any clinical trial is to find new ways to help patients. “Improving patient recruitment processes is a key factor in avoiding costly delays in bringing new drugs to market.” Physicians can feel more motivated to participate in a trial when they are reminded that the trial is a key part of bringing new therapies to market, which will help their patients in the long term.

 

Fostering Awareness

Inadequate exposure is another reason recruitment fails; research teams must make sure the referring physicians know about trials and are reminded about them just as much as the investigator physicians. “Make sure referring physicians are copied on all the emails. Keep them in the loop so they are reminded that they are part of the team.”

Fostering awareness has a lot to do with strategic advertising. Alex Mouravskiy, Biorasi’s Chief Marketing Officer, offers additional advice on getting the word out: “It’s important to remember that while drug trial registries exist, they aren’t terribly easy to use or intuitive. Moreover, many practicing physicians aren’t aware of their existence, and most certainly don’t check them regularly. Promoting the availability of your trials is your responsibility, and it goes beyond relying on investigators to find patients. Setting up lunch and learns or dinner roundtables for your investigators and a pool of potential referring physicians is a fantastic tactic to get the word out about your trial and has worked extremely well for Biorasi in the past on difficult-to-recruit trials.”

 

The Big Picture

In addition to the specific solutions above, Norris also helped us to understand the larger scope of referring physicians’ reservations and related issues to trial recruitment. “Compassion and education are important elements here. You [the recruiter] are not steering patients into research but allowing them to make an informed decision with their healthcare providers.” This might be one of the biggest decisions a patient, along with their PCP, makes in their entire life.

An extra piece of advice Norris gave us has to do with the point of contact between the referring physician/patient and the clinical trial sponsor/CRO, a frequently underprioritized factor. Sometimes, a CRA is enlisted to recruit patients for a study. “Remember that, above all, CRAs are the face of the CRO/sponsor to the site, so they are responsible for maintaining a good relationship. Many CRAs are new to the job, and it’s asking a lot of them to be responsible for patient recruitment on top of their other roles.” Norris says that her “ideal approach to assisting sites with patient recruitment is having a dedicated, specialized person to assist sites with recruitment, not a busy, newly-hired CRA, not a nurse or physician, but a site recruitment liaison.” Another option, she says, is to require CRAs to go through additional training for recruiting. “Recruitment really requires ‘soft skills’ such as conflict resolution.”

 

PCPs and referring physicians can be a powerful force for recruitment if they’re approached correctly and educated on the process of the research and its benefits. Biorasi understands how to reach them and gets assistance from companies like Benchworks when needed.

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

© Copyright 2018 Biorasi, LLC. All rights reserved.

Download a Sample Rescue Trial Report

Please provide your email address so we can email your sample rescue trial report.