A New Kind of Clinical Research Requires a New Kind of CRO:
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A New Kind of CRO That Is Ready for…
The new realities of precision medicine
Technology has radically altered the path of treatment. Cheaper genetic sequencing and the advent of new biomarkers has opened the door to personalized, targeted medicine, but also to a new reality of difficult recruitment and extremely complex protocols.
Is your CRO ready for the new realities of precision medicine?
The unique challenges of rare disease trials
Treatments for rare disease make up more than half of annual drug approvals. These clinical trials bring new challenges with patient populations that are small and globally dispersed. Successfully completing these trials requires a partner designed to navigate these complexities.
Is your CRO ready for the unique challenges of rare disease trials?
The future of complex clinical research
The overall complexity of clinical research is increasing rapidly. Protocols now contain more procedures than ever, patient data is easier to collect but more difficult to manage, regulatory guidances are struggling to keep up with scientific advances.
Is your CRO ready to guide you in the future of clinical research?
What Defines A New Kind of CRO?
Programs, Not Trials
You think in terms of programs and pipelines, not individual trials. We do, too. We seek to support your entire development program, not just the trial in front of us.
We don’t allow tunnel vision to set in. Biorasi is constantly looking for ways to help you optimize and improve your entire therapeutic pipeline. From finding new regulatory pathways and venues, to identifying follow-on indications.
Patients, Not Sites
Your challenge is recruiting the right patients, not finding the right sites. Our challenge is to help you find those patients wherever they are.
Thinking in terms of patients allows us to break away from the traditional reliance on sites and go directly to where your patients are. The result is faster recruitment of higher quality patients, especially in complex and difficult to recruit trials.
Data Science, Not Data Management
Your trials generate a lot of data – over 3 million individual points. But is that data being harnessed to help your trial and your program?
We leverage advanced analytics and techniques inspired by big data processing to put your clinical data to work. Instead of simply collecting, we process from the beginning, giving you deep insights and a strategic advantage from the start.
Transparency, Not Reporting
Your trials run 24/7, with new activity daily. So why do you only get reports once a week, if that? Knowing that your trial is on track requires transparency unlike anything the industry has seen.
We believe that you should own your data, and should be able to access it anytime and anywhere, in real time. Our TALOS™ Control Center gives you minute by minute updates, so you know what’s happening right now, not last week.
Structured Methodology, Not Ad-Hoc Project Management
Clinical research is becoming more complex, while the level of clinical project management stays the same. This divergence is not sustainable.
We began with a structured methodology to clinical project management and certified project management professionals. It’s why we are able to deliver your trials on time and on budget, and why we can say we’ve never needed trial rescue.
Our Core Values
Relentlessly Pioneering
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You pioneer the science, Biorasi pioneers a better approach to clinical research. We push the boundaries of complex trials, and find ways to improve your whole program.
Insanely Efficient
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We were built to be smarter, faster, better. More integrated in our teams and our technology. Making better use of your data. And delivering better results.
Fearlessly Accountable
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We give our sponsors unparalleled transparency into their trials. Best in class tools like the TALOS™ Control Center give you full ownership and hold us accountable to deliver.
Partner Obsessed
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Your success is our success, and your priorities are our priorities. We don’t believe in the terms “client” and “vendor” – we believe in building true lasting partnerships.
Latest Publications
How Dermatology Research Gaps Represent Untapped...
Gaps in dermatological research present potentially lucrative market opportunities for pharmaceutical companies. Patients that suffer from skin conditions and diseases also benefit. Effective treatments relieve irritating, chronic, and often painful symptoms, which...
How the Right Oversight Assures Clinical...
A clinical trial's operational efficiency depends on a solid oversight and response mechanism. Without vigilant monitoring, patient safety, data integrity, and the overall health of your trial come into jeopardy.
How to Launch a Successful, Cost-Effective...
Many neurological conditions, including cerebral palsy, ADHD, epilepsy and autism, manifest either at birth or during childhood. Developing treatments for these diseases is challenging enough. Add to that the clinical, ethical and...
Rare Disease Spotlight: C3 Glomerulopathy
C3 glomerulopathy (C3G), a rare kidney disease, affects only two or three people out of every one million. That’s only a couple people out of the entire population of San Jose, California...
Prepare for Success: How Advance Planning...
It’s rare for any large project that involves hundreds of individuals and multiple locations to proceed without some sort of hiccup. Budgets get stretched, schedules run behind, key staff members move on....
Modern Challenges in Movement Disorders Clinical...
Movement disorders such as Parkinson’s disease, ataxias, tremor, dystonia, tics, Tourette’s, and dozens of rare diseases, affect nearly 40 million Americans. They’re usually chronic, often progressive, and rarely curable. As our population...
Determining the “ROI” of Clinical Trial...
Have you ever put off talking to your significant other about expensive-but-necessary home repairs, for fear they’ll hit the (leaking) roof? Most of us have, and if we haven’t, we’ve put off...
Are Cannabinoid-Derived Drugs the Future of...
Less than a year ago, FDA approved the first cannabinoid-derived drug, Epidiolex. It’s a pivotal development for a few reasons: It’s the first FDA-approved drug to contain cannabidiol (CBD), a chemical component...
The Power of Patient Registries: How...
Each year, doctors diagnose about 1,000 Americans with cystic fibrosis, a rare hereditary disease that affects about 30,000 people in the United States. Thanks to advances in treatment, people with cystic fibrosis...
Is Gut Microbiome Behind Our Next...
“Microbiome” has become a consumer product buzzword, found in advertisements for soap and dozens of foods that contain “friendly bacteria.” Meanwhile, the scientific community is discovering new connections between the microbiome and...
Patient Recruitment Solution: How to Ease...
The numbers vary but multiple surveys confirm what we all know: patient recruitment is one of the most challenging and important aspects of running a clinical trial. A 2017 Tufts survey reported...
Cellular Therapy in Neurological Diseases: The...
Neurological disorders and diseases affect all ages and ethnicities, and most result in long-term disability and irreversible conditions. A paper published in the Annals of Neurology reports the nine most common neurological diseases cost...
Advances in Non-Opioid Options for Post-Operative...
In a statement last August, departing FDA Commissioner Scott Gottlieb outlined several steps the agency had planned to further address the opioid crisis. Part of that approach, he wrote, includes supporting development...
Introducing Biorasi’s Center of Excellence: Neurology...
Advances in stroke management, the first cannabinoid-derived drug approved, new therapeutics for progressive multiple sclerosis, early signs of successful treatment of diabetes and myocardial infarct via stem cell therapy…these are a few...
When Virtual Trials Are Not the...
Next to cost, patient recruitment, enrollment, and retention are top concerns for sponsors, sites, and others involved in clinical trials. Will virtual clinical trials ease these challenges and reduce the 90% failure...
Dermatology Detectives: How the Right Principal...
The principal investigator (PI) plays an important role in a clinical trial, regardless of therapeutic area. When conducting complex dermatology clinical trials with difficult to treat, rare, or complicated skin conditions, the...
How to Minimize Subjectivity in Dermatology...
The success of any clinical trial depends on unbiased data. However, the subjective nature of many dermatology assessments makes unbiased data harder to come by. Inconsistent reports based on subjective findings can...
Is Your Clinical Trial in Need...
A 2018 study out of MIT Sloan School of Management showed only 13.8% of drug development programs lead to FDA approval. That’s an improvement from previous estimates, which hovered at around 10%,...
Cosmeceuticals: How to Navigate the Legal...
The cosmeceuticals market continues its steady climb upward—a rise in disposable income plays a role, as well as the introduction of new ingredients that promise anti-aging, photoprotective, redness-reducing, and other skincare enhancing...
What is the Skin Microbiome?
A current Dove soap ad asks, “Is your body wash microbiome gentle?” Do you need microbiome gentle soap? And what is your skin microbiome anyway? We’ll answer these questions one at a...
Challenges in Dermatology Device Clinical Trials...
Rising concerns about aesthetics has led to increased demand for hair- and skincare procedures. In addition, rates of skin disorders such as psoriasis, acne, eczema, and skin lesions have increased, primarily due...
The Current Standing of Research on...
Wound healing is a complicated and dynamic process that includes multiple overlapping phases. Adequate wound healing is crucial to avoid risk of infections, prolonged hospitalization, and poorquality of life. ...
Shortening the pharmaceutical development lifecycle and...
Shortening the pharmaceutical development lifecycle and reducing costs with IBM Clinical Development® Overview: Costs, overheard and time spent are factors Biorasi strives to reduce for its partners in complex clinical trials. IBM...
Post-Brexit Implications for the Pharmaceuticals Industry
On June 23, 2016, United Kingdom (UK) voters decided to leave the European Union (EU) in the closely fought Brexit (British+Exit) referendum. Although a withdrawal deal, if there is one, remains in...
Press Release: Leading Global CRO Hires...
Celebrated Industry Veteran to Lead Scientific, Medical, and Regulatory Affairs at Biorasi Miami, FL, Jan 29, 2019 (GLOBE NEWSWIRE via COMTEX) — Miami, FL, Jan. 29, 2019 (GLOBE NEWSWIRE) — Biorasi, a...
Rescue Is Not A Dirty Word:...
3 Measures to Overcome Operational Failures 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...
What Are The Advantages of Virtual...
In this blog post, we will try to understand Virtual Clinical Trial. As technology continues to become better and more integrated into the clinical development industry we are seeing increasing interest in...
SCOPE 2019
Biorasi will be attending and exhibiting at the SCOPE 2019 Annual Meeting from February 18-21 in Orlando, FL. We would like to extend a cordial invitation to all of our partners, sponsors,...
AAD 2019
Biorasi will be attending and exhibiting at the AAD 2019 Annual Meeting from March 1-5 in Washington, DC. We would like to extend a cordial invitation to all of our partners, sponsors,...
Introducing Biorasi’s Center of Excellence: Dermatology
Biorasi has a solid track record of experience in dermatology, and our goal for this year is to share all corners of our knowledge on the topic while highlighting a few of...
AAN 2019
Biorasi will be attending the AAN 2019 conference from May 4-10 in Philadelphia, PA. We would like to extend a cordial invitation to all of our partners, sponsors, and friends to meet...
BIO International 2019
Biorasi will be attending and exhibiting at the BIO 2019 conference from June 3-6 in Philadelphia, PA. We would like to extend a cordial invitation to all of our partners, sponsors, and...
DIA Global 2019
Biorasi will be attending and exhibiting at the DIA 2019 Global Annual Meeting from June 23-27 at the San Diego Convention Center. We would like to extend a cordial invitation to all...
Immuno-Oncology Summit 2019
Biorasi will be attending and exhibiting at the Immuno-Oncology 2019 summit from August 5-9 in Boston, MA. We would like to extend a cordial invitation to all of our partners, sponsors, and...
World ADC 2019
Biorasi will be attending World ADC 2019 from October 10-11 in San Diego, CA. We would like to extend a cordial invitation to all of our partners, sponsors, and friends to meet...
CNS Summit 2019
Biorasi will be attending CNS Summit 2019 from October 31 – November 3 in Boca Raton, FL. We would like to extend a cordial invitation to all of our partners, sponsors, and...
ASN Kidney Week 2019
Biorasi will be attending and exhibiting at the Kidney Week 2019 conference from November 5-10 in Washington, D.C. We would like to extend a cordial invitation to all of our partners, sponsors,...
ASH 2019
Biorasi will be attending ASH 2019 from December 7-10 in Orlando, FL. We would like to extend a cordial invitation to all of our partners, sponsors, and friends to meet with one...
Commonalities of Rare Diseases
Collectively, rare diseases affect a huge number of people: about 25 million in the US and 400 million globally. To qualify as a rare disease per the US standard, fewer than 200,000...
New FDA Guidance for NASH Drug...
Just in time for our final follow-up to the two previous articles on non-alcoholic steatohepatitis (NASH), the FDA released a new draft guidance for drugs being developed to treat the disease. In...
Press Release: Biorasi Partners with RLH...
Florida-Based CRO seeks to expand offerings, global footprint, and headcount after successful investment transaction. Biorasi, a leading full-service global contract research organization (CRO), is excited to announce that it has successfully...
The Future of Diabetes Treatment
Type 1 diabetes affects millions of people in the US alone. What’s worse is that the majority of patients do not achieve good control of their blood glucose levels. Management of type...
A Deep Dive into NASH Physiology...
In the clinical trial world, we spend a lot of time focusing on phase I-IV trials, and it’s easy to forget about the very important preclinical, basic science studies that go into...
How Virtual Trials Support Patient-Centricity
Revolutionizing Clinical Research: How Virtual Trials Support Patient-Centricity In this digital age, virtual trials may very well become the norm at some point in the future, but there are many questions to...
How Managers Can Establish Good Working...
Authors: Geetesh Shrivastava, Associate Director of Clinical Monitoring; Jennifer Dennis-Wall, PhD, Lead Scientific Writer Back in August, we published a blog addressing themes that are important for sponsor partners to follow so...
Considerations for Working with Research-Naive vs....
When recruiting patients with hard-to-enroll indications, such as rare diseases, it is sometimes necessary to dip into creative resources for finding sites. Sometimes this means looking across the ocean, or sometimes there...
Why Aren’t There Any FDA-Approved Drugs...
The liver does many important things in the body, such as filtering of the blood and metabolizing all compounds, including food and drugs, that enter the body. In that vein, liver disease...
10 Lessons On Success in Asia-PAC...
Earlier this year, a few of us attended DIA 2018 to represent Biorasi. While there, we were fortunate enough to be able to give a talk about some of our experiences entitled...
You’re Holding Your Eye Drops Wrong...
Last week, one of our resident experts in ophthalmology, Ignacio Handal, gave a training for some of our current studies with a focus on which pitfalls to avoid specifically in ophthalmology trials....
A More Complete Scope for Advances...
When people think about women’s health, especially during the month of October, they may think only of breast cancer or reproductive disorders. The truth, though, is that women’s health encompasses so much...
The Politics of Investigator-Initiated Trials
Many clinical trials are initiated by a pharmaceutical company in order to generate data to submit to the FDA for drug approval. Investigator-initiated trials (IITs), on the other hand, are conceived by...
Six Things We Can Do Now...
“What we need to do is to keep working on getting biomarkers more defined to be able to differentiate between the different etiologies. This is going to be the path forward.” Chronic...
Tactful Strategies Steer a Failing Trial...
Tactful Strategies Steer a Failing Trial to Safety Overcoming More Than Just Language Barriers The Challenge: Global studies are notoriously complicated with language barriers, time zone differences, and oft-contradictory regulations. These business...
The Tumultuous History of Women’s Involvement...
Inclusion of women in clinical research has a surprisingly colorful history. As you can probably imagine, inequality is present throughout, but for reasons that may not be so intuitive. If you...
Managing Alzheimer’s Trials in a Diverse...
Patients with Alzheimer’s are not treated the same everywhere. On a global level, this is immediately evident between countries through differences in diagnostic criteria. Even on a more local level, racial and...
Five New Tech Options to Use...
Have you heard of virtual clinical trials? They are trials in which patients can do most of their study activities from home instead of traveling to a study site. A true virtual...
How are Adaptive Trial Designs Improving...
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...
Reservations Held by Referring Physicians in...
Some physicians are reluctant to participate in clinical trials as a referring physician. This is a huge issue because a large portion of participants can come directly from a referring physician’s office....
Advanced Analytics for the Monitoring of...
Advanced Analytics for the Monitoring of Clinical Trials What if there was a way to harness all this data we’re collecting and turn it into a strategic advantage for our clinical trials?...
A Patient-Centric Approach Rescues Complex TBI...
A Patient-Centric Approach Rescues Complex TBI Study Improving Communication to Boost Patient Retention The Challenge: Site selection is one of the most crucial parts of planning a study. Ensuring that sites are...
Five Lesser-known Facts about Sun Exposure
Labor Day weekend is upon us! This means that many of us will be outdoors, if we’re lucky. Methods for preventing sun damage have not changed much in a while: cover up,...
Don’t Let Summer Obstacles Catch You...
There are physiological and logistical challenges to running studies in the summer. We present some solutions.
Biorasi Joins Nova Southeastern University to...
Leading Florida-based Contract Research Organization Partners With University to Train Tomorrow’s Medical Research Professionals Miami, FL, Aug. 09, 2018 (GLOBE NEWSWIRE) — Biorasi, a leading full-service global contract research organization (CRO), is...
Eight Sponsor Essentials for a Successful...
It’s pretty common for a pharmaceutical company to have a list of demands ready when choosing a CRO partner for a clinical trial. Here at Biorasi, we have some demands of our...
Using Precision Medicine in Cancer Trials
Why is it that when we take 50 people of similar height and weight and measure their fasting blood glucose, we get 50 different results? Shouldn’t they be pretty much the same,...
The Future is Here for Clinical...
Mobile phone apps and wearable devices have a lot of potential to improve clinical studies. However, the rules governing them are complex, varied, and not fully developed. It is important to be...
Site Selection Process—How the balance of...
Site selection is one of the most important steps in the clinical trial process; nevertheless, it can be the most daunting. With over 272,000 registered clinical trials worldwide, finding respectable and high-quality...
An Animal Study That You Won’t...
A recent study is making history in the field of Alzheimer’s research. For a long time, scientists have been trying to understand how neurodegenerative diseases, such as Alzheimer’s and dementia, develop. This...
Teamwork: An Evidence-Based Approach for Trial...
Every clinical trial comes with its own unique challenges. Sometimes the biggest challenge faced by a trial is simply not enrolling enough participants. Well-documented reasons for challenges with recruitment can stem from...
Biorasi Spotlight: Iulia Tath – Intern
For this week’s Biorasi Spotlight, meet Iulia Tath, Intern, at Biorasi, LLC. How did you become interested in clinical research? As an undergraduate student majoring in Biology, I worked with the University...
Biorasi Recognized for Best in Class...
Biorasi is proud to announce that leading industry publication Global Health & Pharma, also known as GHP News, has recognized the company twice in their 2017 Pharmaceutical Industry Awards. Biorasi Executive Vice...
Bolstering Enrollment in Parkinson’s Trials: Patient...
Novel treatments, accurate biomarkers and efficient diagnostic tests are direly needed in the fight against Parkinson’s Disease (PD), the second leading neurodegenerative disease in the world. One major avenue to support biomedical...
Special Considerations for Clinical Trials in...
Clinical trials in neurological diseases often mirror the complexity of the disease itself. Hence, a team tackling this type of clinical trial should make a number of assumptions, some of which are...
Non-Traditional Trial Recruitment Strategies for Non-Traditional...
Innovative and out of the box methods are often required for the recruitment of challenging populations in clinical trials that would otherwise fail miserably when using conventional recruitment strategies. In this arena,...
Tweaking Study Designs to Increase Enrollment...
Many of us typically think of Alzheimer’s Disease (AD) when we hear the word “dementia”. This is a fair assumption since AD is indeed the most common type of dementia, and accounts...
An Intern’s Glimpse into the World...
As a Master of Health Administration (MHA) candidate at the University of Miami and a Program Development intern at Biorasi for the last four months, I had the unique opportunity to take...
What to Look for When Selecting...
Risk-based monitoring (RBM) is heralded as the new solution to all troubles in clinical research – the exorbitant complexity, the ridiculous costs, the nerve-wracking SAEs. Sponsors and CROs are gradually adopting RBM, but...
Not Enrolling Enough? How to Rescue...
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...
Avoiding the Blame-Game in Rescue: Don’t...
Introduction Clinical trial rescues can often be a delicate topic for both sponsor and contract research organization. When a study goes off track, it’s natural to want to point fingers and look...
Dermatology Expertise Helps Biorasi Recruit In...
Dermatology Expertise Helps Biorasi Recruit In Challenging Conditions Intelligent Processes Overcome Enrollment Barriers The Challenge: Patient compliance was a serious concern, particularly regarding the reduction of sun exposure. Running a dermatology trial,...
An Innovative Approach to Solve an...
An Innovative Approach to Solve an RLD Shortage Intelligent Project Management to the Rescue of a Scabies Generic Trial The Challenge: Limited or no availability of the Reference Listed Drug (RLD) for...
Biorasi Opens Japan Office
Leading Global, Full-Service CRO Expands Clinical Trial Management Presence in Asia Biorasi, a leading full-service global CRO, is pleased to announce today the opening of their new Japanese office, located in Tokyo....
Stem Cells?! What are they? How...
Introduction Stem Cell Therapy is one of the most important biomedical discoveries in recent history, with far-reaching potential effects on a wide range on individuals afflicted with numerous diseases. Nonetheless, basic knowledge...
Holiday Hurdles in Clinical Research
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...
Strict Processes Rescue Complex MS Trial
Strict Processes Rescue Complex MS Trial Biorasi’s Project Management-first Approach Allows Rapid Feasibility and Site Startup to Meet Critical Deadlines The Challenge: A specialty pharmaceutical company engaged Biorasi to rescue their phase...
Stem Cells: Myths and Misconceptions in...
Stem Cell therapy constitutes one of the most hailed advents in medicine for its potential in treating many of the chronic and difficult diseases like Traumatic Brain Injury, Diabetes and Cancer. However,...
Quintessential Guide to Planning a Clinical...
The Quintessential Guide to Planning a Clinical Trial Clinical trials are complex undertakings, with complex planning required. Success or failure is often determined long before the trial even gets underway. Biorasi’s quintessential...
Pioneers Tackling Interchangeability in Biosimilars
With a global market of USD 3.3 billion during 2016 and a forecast surpassing USD 10.5 billion by 2023, Biosimilars have received more than their fair share of hype in the pharma...
The IgAN Enigma
Immunoglobulin A (IgA) is an antibody manufactured by the body’s immune system to protect against invaders. Immunoglobulin A nephropathy (IgAN) is a common kidney disease where too much IgA is deposited into...
Breast Cancer Month: Better Trial Enrollment...
Despite an extremely encouraging 38% decrease in mortality since 1989, Breast Cancer remains the most common type of cancer in the US. Indeed, it is estimated that in 2017, there will be...
Upcoming Advancements in the Treatment of...
Approximately 60,000 Americans are diagnosed with Parkinson’s disease each year, and more than 10 million people worldwide are living with Parkinson’s disease (PD). With no predictive lab test or cure, PD is...
Reprogramming the Mind: Virtual Reality Exposure...
According to the CDC, post-traumatic stress disorder (PTSD) is one of the most common mental disorders present in the general population. In the United States an estimated 8% of the population, over...
Skin So Simple: Myth Busted
Clinical research in dermatology has a reputation for being simple and easy to conduct compared to other therapeutic areas. Developing therapies for the largest organ in the human body is not an...
Biorasi Spotlight: Jennifer Royzis – Lead,...
For this week’s Biorasi Spotlight, meet Jennifer Royzis, Lead, Talent Acquisition at Biorasi, LLC. How did you get into clinical research? I would say by accident but obviously, there’s more to it....
A Modern Approach to Patient education...
A Modern Approach to Patient Education Increases Enrollment Interactive Solution Increases Enrollment And Compliance With Injectables Download Case Study The Challenge:Running a trial for dermatology injectables when topical alternatives exist presents unique...
Traial Planning Save ALBP Trial some...
Biorasi Rescue Effort Doubles CNS Trial Enrollment Rate Leveraging experience to predict problems before they affect clinical trial deliverables Download Case Study The Challenge:Not every study presents a completely new and unique...
Biorasi’s TALOS™ Platform and Unique Sites...
Biorasi’s TALOS™ Platform and Unique Site Win Unusual ANDA Trial Flexibility and Strong Process-driven Planning Overcomes Regulatory Speedbumps Download Case Study The Background:ANDA approval for therapies going off-patent are typically a staid...
Operating a Pharmacovigilance Group in a...
Operating a Pharmacovigilance Group in a Multicultural Global Environment The way an individual interprets language is influenced by many factors, including culture, background, education, training, and personal biases. Download White Paper
Optimizing Ophthalmic CE ANDA Trials
Optimizing Ophthalmic CE ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper
Navigating through the Clinical Trial Authorization...
Navigating through the Clinical Trial Authorization Process in Russia Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper
Patient Numbers Required In Clinical Endpoint...
Patient Numbers Required In Clinical Endpoint ANDA Trials Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper
Optimizing the Amount of Investigational Materials...
Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two For Dermal Semisolid Clinical Studies White Paper Series Download White Paper
Optimizing the Amount of Investigational Materials...
Optimizing the Amount of Investigational Materials in ANDA Studies – Part One Clinical Endpoint ANDA Program Optimization White Paper Series Download White Paper
Five Signs Your Clinical Trial Needs...
By some estimates, more than 90% of drug candidates never make it into consumer hands. That number shouldn’t come as a surprise to anyone who has spent time in pharma R&D, but...
Biorasi Spotlight: Mark Vieder, RPH, MBA...
For this week’s Biorasi Spotlight, meet Mark Vieder, RPH, MBA, Vice President of Drug Safety and Pharmacovigilance at Biorasi, LLC. 1. How did you get into clinical research? Being a health care...
The Decision on Timing in the...
This week, the path to market for biosimilar developers cleared up just a bit. The Supreme Court made a final decision in the three-year lawsuit between Amgen and Sandoz that sets a...
Emerging Challenges in Global Clinical Studies
Clinical research is going global. This growth translates to sponsors no longer running separate studies in each and every country they are seeking marketing approval; instead they are opting for large, global...
Biorasi Spotlight: Phoevos Hughes – Senior...
For this week’s Biorasi Spotlight, meet Phoevos Hughes, Senior Project Manager at Biorasi, LLC. 1. How did you get into clinical research? The short version – sheer luck. The long version…...
Advances in Early Alzheimer’s Detection
The prevalence of Alzheimer’s disease (AD) is rapidly increasing as individual life spans across the world increase. It is currently the most common form of dementia, marked by the overproduction and aggregation...
Biorasi Spotlight: Mari Heghinian, PhD –...
For this week’s Biorasi Spotlight, meet Mari Heghinian, PhD, Manager of Program Development at Biorasi, LLC. 1. How did you get into clinical research? After graduating with my PhD, I joined...
Can Big Data Rescue Clinical Trials?
If you had to pick one buzzword that perfectly encapsulated the current latest and greatest in innovation, you could do a lot worse than “big data”. The last few years have seen...
Clinical Endpoint ANDA Program Optimization Introduction
Clinical Endpoint ANDA Program Optimization This introduction marks the launch of a series of White Papers dealing with the optimization of Clinical Endpoint ANDA Programs for the generics and specialty pharmaceutical industry....
Trial Rescue Effort Doubles CNS Trial...
BIORASI RESCUE EFFORT DOUBLES CNS TRIAL ENROLLMENT RATE Patient Enrollment Needs To Be Strategic, Not Just Tactical Download Case Study Almost every company that has ever run a trial finds themselves, at...
How To Better Manage the Complexities...
Managing the Complexities of Clinical Trials in the Dialysis-Dependent CKD Population Chronic kidney disease is a serious, slowly progressing condition, culminating in end-stage renal disease. Developers of treatments for this condition face...
3 Trends in Biosimilars: A 6-Year...
Over the next five years, the purchase and production of biosimilar drugs can expect to see double-digit growth. As biosimilar drugs become more widely produced, prescribed, used, and accepted, the competitive marketplace will...
The Most Common Reasons for Trial...
The study is behind schedule. Enrollment is lagging. The protocol is too complicated. Approximately 80 percent of all clinical studies need intervention or optimization to be successful, but only about 10 percent get...
Implement CDISC Standards for Faster Reporting...
The Clinical Data Interchange Standards Consortium (CDISC) created standards designed to streamline clinical research data and essentially enable reviewers to more fully assess the efficacy and safety of a product. In 2014,...
The Promise of Biosimilar Drugs
In 2006, the European Medicines Agency granted its first approval of a biosimilar drug, the human growth hormone, Omnitrope™ (Sandoz), and opened the doors of opportunity for this emerging field of medicine. In 2010,...
Creating High Performance Pharmacovigilance Teams in...
Individuals often interpret the same information and terms in dramatically different ways. Multiple factors drive these variances, including culture, background, education, training, and personal biases. Unfortunately, this means when diverse global teams...
Biorasi Joins GPhA Biosimilars Council to...
There is great strength in numbers, and joining forces with some of the world’s most influential companies in the biosimilar industry will position Biorasi to have a more significant impact on biosimilar...
Clinical Research Optimized ™ Powered by...
Biorasi delivers Clinical Research Optimized ™ for Biosimilar clinical trials, proving success in some of the most complex trials in the industry. Multi-dimensional trial challenges require superior professional project management. TALOS™, our...
Biorasi is Your Preferred Provider
Biorasi has been engineered internally to deliver sponsor partners optimal clinical trial results, especially, for Biosimilar Studies. We understand the importance of strong, dependable relationships and pride ourselves on being the support...
June is Men’s Health Awareness Month
Biorasi conducts life-impacting drug studies for Men’s Health; now, if they only showed up to the Doctor. Biorasi is taking the opportunity in June, Men’s Health Awareness Month, to encourage men and their loved ones to take a closer...
It’s your life; live it well....
It’s your life; live it well. Healthy Options are Key It can be hard to maintain a healthy lifestyle when working traditional 9-5 business hours. It is likely you sit at a...
Mental Health Awareness, Part 2: Spotlight...
In September 2014, TIME called Iodine “The Yelp of Medicine,” founded by former Wired editor, Thomas Goetz and Google engineer, Matt Mohebbi, the startup offers a user-friendly database of drug information. Iodine...
Mental Health Awareness, Part 1: #B4Stage4
1 in 5 American adults will have a diagnosable mental health condition in any given year. 50% of Americans will meet the criteria for a diagnosable mental health condition sometime in their...
Parkinson’s Disease, Part 3: The Importance...
Parkinson’s is a disease uniquely and inextricably tied to its community. Patients share symptoms, treatments, difficulties and experiences. Most importantly, they also share in the mystery of Parkinson’s disease. The causal mystery...
Job vs. Career? The Biorasi Difference
A few years ago the news and shelves were filled with articles about Millennials entering the work force. The general consensus seemed to be this new era of workers were spoiled, entitled,...
Parkinson’s Disease, Part 2: Real-time health-tech...
As wearables gain popularity and health related applications rank higher on consumer needs; the health-tech industry is rapidly evolving. 2012 marked the new era of “health-tech” with Sage Bionetworks launching voice recording...
Parkinson’s Disease, Part 1: The Importance...
Imagine: Losing total control of physical and mental motor skills Taking simple things for granted such as holding a pen, a hair brush or tying a shoe Knowing life with these symptoms...
A Perfect Match
Today we can do more on our smartphones than desktop computers could a mere ten years ago. Smartwatches have officially left the idea boards and have become very real devices; albeit with...
Aiming Higher in Dermatology Clinical Trials
Let’s start with the basics. Dermatology is the branch of medicine dealing with hair, skin, nails and all its diseases. At a very simplified level, Dermatology treats visible ailments. Patients and doctors...
