From designing new clinical trials to finding solutions to statistical and regulatory issues when trials run into roadblocks to assisting with FDA submissions, clients rely on our experience, expertise, and innovative thinking to deliver reliable results. We specialize in human clinical trials of medical devices and academic research projects.
Design.
We specialize in designing clinical trials to secure FDA approval of a drug or medical device.
We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.
We have an unmatched track record in orthopedics in particular.
Analyze.
We analyze ongoing clinical trial submissions and/or after their completion. This includes conducting routine analyses such as Annual Reports, providing Tables, Listings, and Figures (TLF), and situation-specific analyses of more complex issues.
We provide sound and trustworthy guidance on how to proceed should statistical or regulatory complexities arise during a clinical trial.
Strategic statistical guidance in the design phase of clinical trials in order to put them in the best possible position for regulatory success.
Expert review of proposed clinical trial design, reporting, and presentation.
Advance.
Submission of clinical trial results to the FDA in accordance with regulators’ expectations.
We work directly with sponsors and in collaboration with clinical research organizations and regulatory advisors.
We respond to inquiries and represent clients in FDA proceedings from pre-submission through panel meetings.
We are trusted and respected by the FDA. Our founder, Greg Maislin, has participated in three of the FDA’s last three orthopedic panels, which reviewed the Barricaid annular closure device, the Cartiva Synthetic Cartilage Implant, and the Vertiflex Superion Implant.
We publish cutting-edge medical research
Data analysis and co-authorship articles in top medical journals with academics and industry leaders.
Collectively, the BSC® team has published over 250 articles in journals including the Proceedings of the American Journal of Medicine, American Journal of Epidemiology, Joint Statistical Meetings, Journal of Spine & Neurosurgery, the New England Journal of Medicine, Sleep, and Quantitative Imaging in Medicine and Surgery.
Collaboration on other non-regulatory projects with industry sponsors, such as white papers and investor communications.