More Areas of Expertise
Our dedication to key therapeutic areas gives us a deep understanding into the challenges and opportunities that are unique to each area.
OUR EXPERTISE IN COMPLEX TRIAL CHALLENGES
Biorasi has over 15 years of experience managing studies in Medical Devices, Autoimmune and Women’s Health, including multiple rare and complex indications. Our experience has allowed us to put together solutions, tools, and highly structured methodologies that exceed industry standards in every way. Our on study analytics allow sponsors to view data in real time and enabling the relevant stakeholders to make informed decisions on their trial sooner, minimizing risks, saving valuable time and money.
More Areas of Expertise
Expertise doesn’t come easy. It takes focus, drive, and a relentless dedication to constant improvement. We specialize in key therapeutic areas where we know we can be most effective and pursue perfection in those specializations with everything we do.
Autoimmune is one of the fastest-growing areas of clinical research, due to increased recognition and incidence of autoimmune diseases. Biorasi can help with all aspects of managing your next autoimmune trial.
Autoimmune conditions are on the rise, and healthcare companies are rushing to fill the newly opening space, launching hundreds of new autoimmune trials. And while it’s not entirely clear why incidence of autoimmune disorders is going up, what is clear is that this is a critical problem that needs to be addressed quickly. From lupus to chronic respiratory ailments to arthritis and other inflammatory disorders, providing top-notch therapeutics is becoming more and more of a priority.
A True Autoimmune Expert
Biorasi is a true autoimmune CRO, employing a team of extremely talented autoimmune specialists who are just as devoted to treating and eliminating these conditions as our sponsors. What’s more, they are backed up by our industry-leading planning, project management, and execution teams. Our unique approach to putting together sponsor teams means your autoimmune clinical trial always has access to exactly the experts you need, when you need them. That’s Clinical Research Optimized™ for autoimmune 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.
More than just Reproductive Health
The Women’s Health space is moving towards concentrating on the overall well-being of women throughout their entire life cycle, rather than their reproductive needs alone. Postmenopausal conditions, including vulvovaginal atrophy, that affect a woman’s quality of life are actively being researched for innovation of new therapies and dosage forms. With the rapid growth of this therapeutic area, the competition to enter into the market quickly is equally present. This quickness can be hindered by restrictive I/E criteria and by variable endpoints. Unpredictable factors like these can lead to unexpected complications when running Women’s Health trials.
Biorasi’s history in successfully running women’s health trials covers the full spectrum of women’s lives. This experience allows Biorasi to identify and proactively mitigate any anticipated challenges, and include one of the many board certified OBGYNs in our site network for successful study completion. Biorasi is capable and ready to provide your next women’s health study with the time, attention, and tailored solutions it deserves.
What are the common issues medical devices face when seeking regulatory approval?
Does my device even need regulatory approval?
Can it be approved in multiple venues simultaneously?
What if my device is a drug/device hybrid?
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.
At Biorasi, we hear questions like these all the time from medical device companies seeking to get their product to market in the United States and abroad. We’ve spent a lot of time, and enlisted a lot of the top experts in the field, to come up with the best answers for our clients and make the device approval proccess as simple and painless as possible. As a true medical device CRO, we offer more than just plans and proposals: we offer answers, and the peace of mind that comes with knowing your device trial is in good hands. Some of our medical device approval services include:
Accelerating the medical device development and approval process takes a special kind of contract research organization. It requires an in-depth understanding of the unique regulatory challenges that devices must overcome and a strong scientific and engineering foundation. It requires anticipating risks and taking steps to preempt them before they turn into problems. Biorasi has the experience and the talent to accelerate your device trial, and to be your trusted medical device CRO partner.