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    • 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.

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        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.
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        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.
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        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.
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        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.

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        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.

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        The Biorasi clinical team achieves unconventional results from rapid site startup, through successful completion of enrollment and the timely lock of the study database.

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        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.

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        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.

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        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.

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        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.

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        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

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        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.

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        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.

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        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.

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        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.

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        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.

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        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.

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        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.

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      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.

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Earlier this year, a few of us attended DIA 2018 to represent Biorasi. While there, we were fortunate enough to be able to give a talk about some of our experiences entitled “Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams” in collaboration with Brian J. Malkin, Esq., legal counsel at Arent Fox LLP. On our behalf, Mr. Malkin shared his and our expertise on a rescue we performed, wherein cultural differences had the potential to hinder successful business relations and management of the trial. We also recently published this story as a case study.

 

Mr. Malkin has a 20+ year history of working with food and drug law practice, including intellectual property law practice. But even more importantly for this topic is Mr. Malkin’s experience working internationally, including nations in the Asia-Pacific (AsiaPAC) region.

 

When working with different cultures, each culture has its own unique set of challenges. It is well-known that Japanese culture is very different from Western culture in terms of how respect is shown. Without a thorough knowledge of exactly what those differences are, it can be difficult to navigate a business relationship. Here are some specific cultural differences and challenges Mr. Malkin included in the talk:

 

  • AsiaPAC workplaces are more formal than Western workplaces. Co-worker interactions are sometimes planned and are more structured compared to Western interactions that are off the cuff or organic.

 

  • AsiaPAC culture and leadership value respect. Individual ideas are also valued, but they need to be worked up through the rungs using a process of common endorsement.

 

  • Compromise is valued, and a face-saving approach in dealing with conflict (e.g., with management) is held in high regard.

 

  • There is a much heavier emphasis on uniform processes and procedures in many AsiaPAC countries – some Western cultures may consider this “bureaucracy.”

 

  • AsiaPAC tends to prioritize groups over individuality, while Western cultures often prize individuality.

 

  • An aggressive “steamrolling” is less effective in getting things done; following procedures and gradually securing the understanding and support (“nemawashi”) of each stakeholder group is the desired and preferred approach to achieve results over the long term. Project managers (PMs) on Western teams should expect to adjust deadlines and expectations as part of the process.

 

  • More than simply a language barrier, a lot of communication relies on shared experiences and understanding – lacking that context often results in overlooking critical pieces of information or plans being impeded.

 

  • Management often secures outcomes before meetings to reduce debate or discussion, giving the potentially false appearance that brainstorming/creative sessions or solutions are frowned upon.

 

  • AsiaPAC culture has a concept called “sontaku.” This is the idea that staff should always be able to infer the will and preferences of their superiors from subtle cues or other indirect behavior.

 

  • There is much more respect for the chain of command in AsiaPAC cultures – a close communication linkage exists between employees and management. This attribute aims at avoiding costly business mishaps and engineering the best business decisions, since the data landscape differs between employees and management.

 

An strong understanding of these concepts and a wide repertoire of interpersonal skills resulted in a successful study rescue that could have otherwise crashed and burned. If you are planning to engage in international business, it is wise to invest in educating the involved team on the culture specific to the country. Learning a bit of the language can also go a long way in showing respect, as long as you are pronouncing everything correctly!

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Biorasi is a full-service, global CRO whose vision is a future where data, process, and technology work together seamlessly to accelerate drug development for the benefit of our sponsors and their patients’ lives.

We are 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.

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