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.
19495 Biscayne Blvd. Suite 900
Miami, FL 33180
Phone: 786 388 0700
Contact: Nadine Alam
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.
A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.
Don’t assume your clinical trial will survive endless change orders, extended deadlines, cost overruns, and missed objectives. Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
The longer you addressing a faltering clinical trial, the greater the risk your trial progresses from faltering to failure. And the deeper a trial's problems, the more likely you'll have to ask for a substantial budget increase—another difficult conversation. Here are some tips to act quickly for the best ROI.
We’re now only beginning to understand how the microbiome influences our health and behavior and vice versa. As we learn more about its connection to a host of diseases and disorders, we expect to see specific bacterial molecules as potential druggable targets.
When used successfully, the virtual clinical trial model promises to enroll more patients faster, improve patient retention, and reduce costs. For all their perceived advantages, a virtual model doesn’t suit all studies. Read some challenges of virtual trials as well as when they do and do not work.
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.
To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.
Clinical research generates a massive amount of data. Unfortunately, because of the way most clinical data programs currently work, much of these data are not used to their fullest extent; they are simply filed away. This white paper will focus on the benefits provided by a unique and advanced analytical approach to study monitoring beyond the minimum necessary RBM approach.
- Every year, tens of thousands of clinical trials are initiated. Every year, thousands of those trials falter, and, if corrective action isn’t taken, some may fail to produce usable data. In this white paper, we want to attempt to characterize the scope of the problem facing the drug development industry, and make a case for early, proactive intervention in faltering clinical trials.
In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to answer before this can become a reality. In this white paper, we propose how virtual trials may be able to solve all these issues at once while also providing the added benefit of reducing costs related to study sites.
Site selection and ensuring that sites are performing up to par are crucial parts of a study. Read how a CRO facilitated communication between participants and sites and personally took measures to follow up with participants who would have been otherwise lost between screening visits.
A specialty pharmaceutical company engaged Biorasi to rescue their phase 2 clinical trial for treatment of spasticity caused by multiple sclerosis (MS) after an incumbent CRO was not meeting enrollment expectations. Read how Biorasi’s project management-first approach allowed rapid feasibility and site startup to meet critical deadlines.
Limited or no availability of the Reference Listed Drug (RLD) for a generic dermatology trial can seriously hinder the feasibility of a study. An innovative approach including the enrollment of patients with very high potential of protocol adherence and effective patient engagement to minimize the rate of retreatment throughout the study resulted in a successful study.
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.