ABOUT BIORASI

Biorasi is an award-winning contract research organization accelerating drug and device clinical development for life sciences companies around the world.  Since 2002, Biorasi has achieved success in bringing innovative therapies to market for our sponsors. Biorasi solves the problem of poor clinical trial performance with better patient recruitment, powerful data insights, and operational excellence. We deliver faster, higher quality clinical trials. Biorasi is headquartered in Miami, Florida, and has regional offices around the globe.

FEATURED PRODUCTS/SERVICES

The biggest issues for faltering trials? Incomplete planning and enrollment issues  can explode into big problems if not addressed early enough. Biorasi offers a no-commitment, no-charge, fast consulting assessment that will identify and correct these issues in your study early – before they grow too big to manage.

CONTACT INFORMATION

Biorasi

19495 Biscayne Blvd. Suite 900

Miami, FL 33180

UNITED STATES

Phone: 786 388 0700

Contact: Nadine Alam

BLOGS

  • Paroxysmal nocturnal hemoglobinuria (PNH) is defined as an acquired rare disease triggered by a rare mutation in bone marrow stem cells, with patients experiencing production of irregular blood cells. In terms of clinical studies, PNH’s uniqueness presents a number of operational challenges. In this article, Dr. Mehool Patel discusses innovations in the treatment of PNH, the diverse nature of this rare disease, as well as solutions for PNH clinical trial enrollment and availability.

  • Have you ever put off broaching a difficult conversation about a faltering clinical trial? Early intervention is a sound solution to putting an at-risk trial back on course.

  • Similar to how the response and immediate action to the “Flattening the Curve” movement in 2020 was executed to dramatically lessen the severity and impact of the pandemic on millions of lives, the actions and strategies implemented in today’s clinical studies will impact how patients in current trials will get their investigational treatments. Without a proactive and comprehensive strategy in place to manage clinical trials during the pandemic, consequences may be severe –especially for those that need the treatment the most.

  • Starting clinical trials in the right direction begins with a well-designed study protocol – the more comprehensive, the better. In this article we discuss some of the more “common sense” best practices to consider during the protocol design process with Dr. Robert Wilkins, former PI and Founder of QPS Consulting.

  • Quicker recruitment means more than just a boost of speed. Biorasi has built our reputation as a fast and flexible leader for CRO solutions, and we are constantly striving to find more innovative and efficient methods for enrollment – inclusive of social media strategies.

  • Patient registries assist orphan drug development by giving manufacturers access to clinical, genetic, and biological data from a large patient population. Using registries, sponsors can better understand the disease, its history, and patients’ needs, all of which benefit clinical trial design and effectiveness.

  • There are no concrete instructions when it comes to RBM, and planning a successful RBM design can be challenging. Even so, we believe investing in an experienced partner to help you with RBM design is worthwhile. RBM can be an indispensable tool for your trial’s success. Following is an out of outline a criteria that could be helpful in finding the right RBM specialist.

  • Big data and data mining are being leveraged to improve drug development, with huge potential implications in identifying and correcting issues that arise during clinical trials. This article is a quick overview of what big data is and how we look at and define program failures and faltering trials.

WHITE PAPERS & CASE STUDIES

  • Paroxysmal nocturnal hemoglobinuria (PNH) is defined as an acquired rare disease triggered by a rare mutation in bone marrow stem cells, with patients experiencing production of irregular blood cells. In terms of clinical studies, PNH’s uniqueness presents a number of operational challenges. In this article, Dr. Mehool Patel discusses innovations in the treatment of PNH, the diverse nature of this rare disease, as well as solutions for PNH clinical trial enrollment and availability.

  • At the start of the COVID-19 crisis a sponsors was facing delays in an ongoing basket trial for rare nephropathies, specifically the completion of two critical project milestones. With a impact mitigation strategy in place, Biorasi was able to meet both data delivery deadlines – keeping the trial on track and completing the first part of the study despite operational challenges caused by the COVID-19 crisis.

  • Although each rare disease is unique, many challenges to the clinical operations required for successful rare disease trials are consistent across indications. Learn more about these common challenges expected during the course of researching rare diseases that must be addressed before progressing to clinical trials.

  • The operational strategy for rare disease trials is markedly more complex than those for traditional pharmaceuticals. The standard responsibilities of maintaining clinical trial protocols, short and long-term schedules and milestones, and project budgets are just a small part of the burden represented by each unique rare disease and its accompanying trial. This white paper explains a three-tiered strategy to allow pharmaceutical companies, sponsors, CROs, and patients to each better their own ROI in the end result.

  • Risk Based Monitoring (RBM) is beginning to feature prominently as the go-to monitoring solution for clinical trials, combining the best of existing monitoring methods with the flexibility needed to keep studies on track.

  • Similar to how the response and immediate action to the “Flattening the Curve” movement in 2020 was executed to dramatically lessen the severity and impact of the pandemic on millions of lives, the actions and strategies implemented in today’s clinical studies will impact how patients in current trials will get their investigational treatments. Without a proactive and comprehensive strategy in place to manage clinical trials during the pandemic, consequences may be severe –especially for those that need the treatment the most.

  • Starting clinical trials in the right direction begins with a well-designed study protocol – the more comprehensive, the better. In this article we discuss some of the more “common sense” best practices to consider during the protocol design process with Dr. Robert Wilkins, former PI and Founder of QPS Consulting.

  • Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.

NEWS

  • Biorasi Joins Nova Southeastern University To Spur Healthcare Job Growth In South Florida
    9/8/2018

    Biorasi, a leading full-service global contract research organization (CRO), is excited to announce two new certificate programs through Nova Southeastern University to provide targeted education and job skills for future healthcare workers in South Florida.  The certificate programs are a joint effort between the two organizations to create a Clinical Research Associate (CRA) graduate certificate program through the university’s Dr. Pallavi Patel College of Health Care Sciences. This certificate program will help prepare students to enter the rapidly growing field of clinical research and provide them with the practical skills and knowledge to secure employment in a well-paying career in the sciences.