• 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


        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

The ability to adapt is a valued attribute in today’s constantly changing world, and clinical trial designs are no exception. Adaptive trial designs can save sponsors significant time and money, but they need to be approached with caution and planning.


Historical context

Study design used to be straightforward and included only a few main types: randomized controlled trials (RCTs), cohort studies, case studies, and the like. The need for adaptive designs, or designs that have dynamic treatment protocols guided by study progress and interim data, arose from the limitations of RCTs. Even though RCTs are considered to be the gold standard, they are demanding financially when large sample sizes and long periods of time are needed to see the desired effect. On top of that, the traditional phase I-IV schema for novel drug development means that recruitment restarts at the beginning of each phase.

Adaptive designs can allow for quicker decisions based on interim analyses. They also often feature shorter study durations (when phases are combined), minimized recruiting efforts (when the same patients from one stage can continue on into the next stage), and a lower overall cost. The FDA even supports these innovations and is putting out new guidance all the time about different trial design options to accommodate ethical and practical considerations.


Current uses of adaptive designs

Many unique trials have used adaptive designs and have contributed significantly to medical research. The INHANCE study (NCT00463567) used an adaptive seamless design to combine a phase IIb (dose titration) and a phase III (efficacy) into one trial. The first stage observed 7 arms over 2 weeks and then paused for an interim analysis to identify the 2 best doses of the experimental drug. The second stage then recruited additional patients to test the efficacy of the drug in the required larger sample size. The final analyses included data from the patients who had participated in the first stage, thus reducing the number of additional patients needed and time to recruit those patients. The study did have some drawbacks: i) they needed an external data and safety monitoring board (DSMB) to select the doses and had to design a very thorough set of procedures for the DSMB to use for this purpose, and ii) interim analyses can often be underpowered if they are conducted before trial enrollment is completed, meaning that the desired sample size has not yet been achieved.

The NCI-MATCH trial (NCT02465060) is an ongoing, open-label, non-randomized phase II trial with over 40 treatment arms and 40 accompanying subprotocols. Instead of sticking to the traditional format of studying one drug per trial, this study employs a genomic screening stage to allocate participants to one of the treatments based on their genetics, rather than based solely on the category of cancer they have. This essentially allows for the work of 40 different trials to be conducted in a single study. Of course, future studies will further investigate any promising drugs identified in this study to establish efficacy in a more stringent design (e.g. randomized, controlled trial). Also, if there are 40 different possible treatments, it is extremely important to make sure the patient is getting the drug they are assigned and avoid mix-ups. Project management and quality assurance become especially high priorities for a study like this.


Issues and considerations

Adaptive designs offer creative solutions to many issues posed by traditional study designs, but they are not without limitations. There are trade-offs of using interim analyses: they give an early indication of the results but can be underpowered and thus possibly inaccurate if all the patients haven’t been enrolled yet. Certain designs, such as unblinded or open-label (which are a common characteristic of adaptive-design trials), are subject to heavier regulatory scrutiny because of the opportunity of investigators to be biased in the interpretation of results. Finally, in order to make decisions mid-study about the study without compromising the study’s integrity, the investigators need to develop very detailed plans for selecting the best doses or treatment arms in an unbiased manner; they almost have to predict all of the possible scenarios and decisions that would be made in each case to avoid this bias. It is also typical for sponsors not to be allowed to select doses or make decisions about treatments in the middle of the study to minimize risk of bias, so DSMBs may be required.


All trials, especially those with adaptive designs, are complex projects with multiple moving parts, requiring precision and planning to pull off. However, sponsors that do the leg work ahead of time can position themselves to reap tremendous benefits. Selecting the right CRO and other vendors is also critical – a strong focus on project management is essential to successfully running a trial with an adaptive design. Also important is a thorough review of all necessary FDA guidance documents and a consultation with experienced biostatisticians when designing trials.

As drug development costs continue to increase, we expect to see significantly more adaptive designs being used. Planning for that transition early can result in significant competitive advantages down the road.

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