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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

    • 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
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With the holiday season upon us, the focus shifts from daily work tasks to planning for vacations and festivities. The holidays can be especially challenging in clinical research where strict adherence to timelines is imperative for success. Many common holiday situations can put a clinical trial at risk if not addressed early on. It is important to be as proactive and flexible as possible to plan for potential problems before they arise.

For example, working with a “skeleton crew” during the holidays can affect a clinical trial greatly if proper planning around staffing does not take place. Early review of the study timelines and activities may provide insight into where efficiencies can be gained or what accommodations may need to be made. Study team and study patient schedules need to be coordinated early on to prevent site resource shortages and protocol deviations. Failing to plan around these sorts of inevitable holiday challenges could result in an undesired outcome for both patients and sponsors alike. Below are some ideas to manage some common “holiday hurdles” in the clinical research industry.

 

Being Smart About Site Start-up

If planning to activate sites over the holiday season, it is important to recognize the disruption caused by site staff travel and time-off, and to keep one’s mind on the “big picture.” From an operational perspective, nobody likes a delay, so the pressure may be to initiate as many sites before the break as possible. However, in many cases it may be more prudent to delay site activation until after the holidays. While a delay may alter the trial schedule superficially, waiting until all key staff are present and engaged will prove beneficial as training efforts won’t be lost over a long break. Furthermore, performing an initiation just after the long holiday allows the study teams to proceed directly into patient recruitment activities when they are working with a full crew. In other words, understanding the effect of the holidays on information retention, engagement and momentum will prevent unnecessary and costly retraining and avoiding a “hurry up and wait” scenario.

 

Mindful Monitoring

It can be difficult to schedule a productive monitoring visit during the holidays as some sites have reduced hours, are closed on days they are normally open, or are just generally unavailable because of PTO. Being proactive and creating a holiday calendar for monitoring visits can help avoid these challenges without jeopardizing study plans. Schedule monitoring visits well before the holiday break or if possible, develop a plan with the site to provide documents remotely so that data can be verified off-site (aka central or remote monitoring) even when site staff is on vacation.

Patients’ schedules also need to be considered. Monitors and site staff should work together to develop plans around each patient in the trial, so that important visits and dosing schedules aren’t missed or delayed beyond protocol allowance. The key is preparing beforehand and providing patients with the tools and information they need before they go on vacation.

 

Avoid Database Lock Delays

If database lock is planned near or during the holidays (it always seems like it is, doesn’t it?), it is important to proactively schedule sufficient time with the PI to sign off on the data so as not to stall the database timeline. Many doctors plan lengthy family vacations during the holidays and are unable to visit clinical sites in person. One way to mitigate this problem is to maintain a constant line of communication with each PI. Make sure the PI has access to the EDC system from his or her home or personal computer so that sign-off can be accomplished even when the PI is unable to come to the site. The additional effort required with troubleshooting access from a different machine is minimal compared to jeopardizing database lock, since timely lock is essential for sticking to project timelines and ultimately a successful trial.

 

Coordinate with Outside Vendors

Everyone is worried about their packages arriving in time for the holidays, however in clinical research timely deliveries are even more critical. Clinical trials run on strict protocols and any delays in IP or biological sample shipments could have a major impact on the trial. It is imperative that medication inventories are done prior to the holidays to ensure stocks are supplied and attention is given to potential issues with sample shipments. For example, arrangements should be made with labs to avoid delays in providing samples and/or results. Special shipping arrangements may be necessary to get specimens and/or products to their destination on time. Perhaps visits must be moved to the following business day to ensure that a courier is working when important biological samples must be picked up.

It is also important to consider the holidays when planning for regulatory submissions as many of these agencies are closed and unable to receive submissions. You should know the last submission deadlines and meeting dates prior to the holidays, and do everything possible to meet those dates. Otherwise, a couple of days delay in submission could easily turn into a delay lasting at least a couple of months. Planning for regulatory submissions early on will help to assure adherence to the project schedule and start the new year off right.

 

Celebrate and Avoid Holiday Stress

The clinical research industry is in the business of discovering therapies to save lives and help patients with unmet medical needs. Even though times can be stressful, especially during the holidays, we must take the time to celebrate and remember what brought us all here in the first place. The most important thing is to keep your perspective cheerful and with a little planning, the holidays can still be a productive time in clinical research.

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.

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