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We are pleased to share with you our new website. Over the past several months, our team has carefully reviewed our processes, capabilities, and offerings in order to provide you with the clearest overview of how we help our clients.
The SCIO approach we take in working with drug and device developers helps bring them to market faster and in a more cost effective manner. The BBCR team specializes in rare disease, and has extensive experience working with regulators and within the confines of ever-changing regulations. Navigating the approval process and even determining a course of action is difficult. We are passionate about leading innovators to the best results.
Our clients who are developing therapeutic for rare and ultra-rare diseases are often faced with challenges during this innovative process. The FDA has recently become amenable to allowing for the adoption of historical data as comparator. Though a great opportunity, it comes with the challenge of how to build the disease’s natural history. We have experience with collecting evidence from multiple sources that will satisfy the FDA.
We have worked diligently to summarize, in our new website, the many situations we experience in developing therapeutics. We hope that you find the site informative. More than anything, our rare disease experience has shown to be very applicable to personalized medicine product development.
We encourage you to contact us with your thoughts, questions and development objectives. We love the challenge of applying our experience to best serve our clients!
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.