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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

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Biorasi Trial Rescue Assessment Report

40% Of Clinical Trials Are At Risk

Is Your Trial In Danger?

The biggest culprit for faltering trials? Incomplete planning can snowball into big problems if not addressed early enough. The Biorasi Study Checkup is a no-commitment, no-charge, and fast consulting assessment that can catch and correct these issues in your study early – before they grow too big to manage. Our Study Checkup will help you uncover:

Study design issues, potential data quality problems

Long term impact and root causes of under-enrollment

Projected budget overruns, logistics failures

Projected timeline delays, missed milestones


Contact us to receive a study checkup from Biorasi.
It’s FAST. It’s FREE. It SAVES trials. 

1 + 1 =

Our Study Checkup Process

Review Study

Our experienced program managers review the study status for issues, oversights, and inefficiencies.

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Identify Red Flags

We identify potential issues and red flags before they put your trial in danger of missing milestones or blowing budget.

Evaluate Trial Success

Using our predictive trial model, we extrapolate your study path so you know where you will be if nothing changes.

The Anatomy of a Study Checkup

The Study Health Checkup is an overview of your trial that identifies red flags that may indicate your trial is in trouble. Our team of industry experts will examine your enrollment, site activation, regulatory status, vendor and data status, and budget. After a thorough review, we will provide you with an easy-to-read report that can be used to shore up problem areas internally, or submitted to a manager or board to help you explain the need for an external intervention.

1. Key Findings

It’s not enough to say “Your study is/isn’t faltering.” We take the time to identify findings, insights, and overall study results specific to your trial that will give you the best picture of what’s happening and what your best options are moving forward. If your trial is at risk of faltering, these will be red flags and potential issues. If your trial is healthy, we’ll use this space to give you ideas on study optimization.

2. Study Concern Priorities

Most clinical trials have some areas of concern at any given point, and some have multiple issues at once. Biorasi’s Study Health Checkup is a full 360 degree look that can spot and highlight current and potential problems. Then, we use our extensive experience as a rescue CRO to prioritize these issues, so you know exactly what needs to be addressed first.

3. Overall Study Health

Not all clinical issues are equal, and no two studies are the same. How can our sponsors know if their study is at risk or if they’re still on budget and on schedule? Biorasi leveraged our knowledge as an industry-leading trial rescue CRO to put together an objective study snapshot, that gives you an at-a-glance view of how likely your trial is to miss key deadlines and milestones.

4. Enrollment Projections

Our Program Management consultants use the data you provide to plot your planned timeline against an extrapolation of what is actually happening with your study. If you are skeptical of the projections you are currently receiving, our independent analysis will give you the tools you need to challenge your existing plan, which could be misguiding your study.

What Our Sponsors Are Saying

Don’t just take it from us, let our sponsors do the talking!

“Biorasi’s study checkup helped us identify some potential weak spots in our enrollment strategy that we had no idea existed. If we waited until it became a problem, it would have cost us more than I care to think about to fix. Since we found it early, we were able to address the underlying problems and the trial completed on time and on budget.

The study checkup is a fantastic tool, and it’s surprising that other CROs are not talking about early study reviews to make sure things are going on track. ”

Small CNS Company

Chief Medical Officer

“We approached Biorasi to see if our clinical trial could be rescued. We were months behind our initial timeline and way over budget. We had a very narrow window that we had to finish our study in, and were nowhere close to being on track.

Biorasi ran a study checkup, and let me know that there was no way to get everything done in the time we had. It was bad news, but it cost me nothing, and I had an answer in days.  It’s refreshing to see an organization in this space that is this honest and upfront, even when delivering bad news. ”

Mid-Size Specialty Pharma

Director, Regulatory and Clinical Operations

“Biorasi came in to do a recruitment rescue for a pivotal study in our lead program. We were behind schedule and not getting any good answers from our incumbent CRO.

They [Biorasi] fixed our recruitment issues quickly, and found other serious issues that would have likely compromised the entire program.

Suffice it to say, we’re sending all future work to Biorasi. ”

 

Large Biosimilar Company

VP, Global Clinical Operations

Biorasi honored in the Inc 500
Biorasi recognized by Life Sciences Leader with a CRO Leadership Award

Frequently Asked Questions

Is the Study Checkup only for trials that are failing?

No, any trial can benefit from an early review by a third-party. Even if your trial is on track, on budget and appears to be completely healthy, a Study Checkup might be able to help you identify opportunities for optimization and improvement. If nothing else, it will give peace of mind to your executives, investors, and other stakeholders.

More importantly, a Study Checkup can often find evidence of emerging issues that have the possibility of turning into much larger problems down the line, giving you ample time to take corrective measures without requiring an extensive and expensive intervention.

How long does it take to get the results?

A typical Study Checkup takes approximately one week to complete, from the time we get all the information we need to the time you have a report in your hands. When designing our study checkup process, we wanted to find an optimal balance between timeliness and depth. A week gives us enough time to accurately and thoroughly review your information and to identify specific, actionable information.

What kind of insights can I expect from the Study Checkup?

The Study Checkup is an overview of the overall health of your trial, and answers the question: “Is my study on track to hit our program goals?” To answer that question, we’ll review the information you provide in the Study Checkup Questionnaire.  This includes such information as your study protocol, start date, site status information, enrollment numbers and enrollment venue strategy, data entry and SDV metrics, and the overall timeline you provide us. We’ll use this information to forecast the likelihood of your trial completing on schedule, and pinpoint some red flags that may indicate your trial is in danger of missing milestones and targets.

If your trial appears healthy, we will let you know and also provide suggestions that may be used to increase the efficiency of your trial. These optimization insights are geared towards helping you complete your trial ahead of schedule and on budget.

If we find that the trial may be at risk, we will provide information on factors that may cause time, budget, or quality threshold overruns. We will also provide suggestions on whether the risks may justify a study intervention, based on the information available to us.

Occasionally, we will encounter a study that is past the point where an intervention can realistically prevent the trial from failing to meeting its objectives. In those cases, we will be as straightforward as possible in presenting you with some potential options to mitigate the currently expected outcome.

How much information will I need to provide and how detailed is the Study Checkup report?

We understand that sponsors might not want a large commitment of time and information for a free consulting report, so we’ve structured the information we collect to provide the maximum insight with the minimum amount of required details from the sponsor. All information submitted is covered under a strict NDA, and remains completely confidential.

Since this is a free product, the report itself is an overview, rather than a deep dive into the inner workings of any given study. It provides a high-level look at whether you can benefit from a trial rescue or not, and is not meant to be a definitive plan of action. Our goal is to balance accuracy against speed and commitment to come up with something that will be genuinely useful for sponsors, without requiring a full-scale consulting project.

Is there a way I can follow up on any of the insights in the report, or get additional details on any of the points?

Our Program Management team would be happy to review your final report with you and go over any of the findings. If you would like to get more detailed and have us take a more in-depth look at your ongoing study, we also offer follow-up consulting projects that require more commitment and information, take more time, but in turn provide more detailed information on the specifics of your study, as well as providing a concrete trial rescue or intervention plan tailored to the specifics of your trial.

If you would like to skip over the free Study Checkup and move straight to the deep-dive assessment, just let us know!

Still Have Questions?

If we didn’t answer all of your questions, feel free to drop us a line anytime. Our solutions team will be happy to explain our study checkup in greater detail!

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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