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Over the past forty years, the drug development process has changed significantly.
In the last twenty years, the industry has invested in gathering scientific data to inform clinical questions.
Since 2000, the clinical research’s primary objective has been to marry feasibility and great science to generate anticipatory and adaptive data. Ultimately, to support go-no/go decisions risk-based and benchmarking oriented.
The industry needs to continue the grow toward patient-centricity with participation and contribution to clinical studies. Patient-centricity trials impose the clinical development process to evolve and become increasingly customized.
For the past 12 years, the BBCR team has promoted customized clinical/regulatory strategies that meet the ongoing drug development transformation challenges, and the FDA calls for more intelligent and innovative clinical development plans.
Our team provides extensive clinical, regulatory, and industry experience required for the development of clear goals, cost-effective trials design, robust clinical data, and flexible road maps before tactical clinical activities start.
BBCR consulting embraces an innovative translational method (THE SCIO METHOD) that merges patient-centricity into the product development strategy.
The BBCR team is constantly updated on the regulatory news and approval strategies to offer our clients the best advice on their product development plan.
In addition, the clinical team at BBCR can provide a broad experience on the clinical plan, study synopsis, and protocol development.
Patient recruitment can be very challenging for most therapeutic areas. Our team will work with you on many fronts to facilitate patient recruitment and retention.
We experience extraordinary success during this COVID 19 pandemic. In 2020, we increased patient enrollment eight times compared to the 2019 enrollment.
The BBCR team is pleased to schedule a free consultation to talk about your needs. Contact us at: [email protected]/bbcr2
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.