Regulatory Scientific and Health Solutions (R-S-S)

Regulatory Scientific and Health Solutions (R-S-S) is an expert consulting firm providing comprehensive biostatistics, regulatory strategy, and health outcomes services to the life sciences industry. By designing optimized clinical trial protocols and navigating complex regulatory agency negotiations, R-S-S helps companies secure timely product approvals and demonstrate product safety.
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Work spans eight practice areas from the group's base in Solihull, England: drug licensing and reimbursement, clinical development, clinical data management, statistical and programming, market access and HEOR, real world data and electronic health records, scientific and health solutions, and a separate veterinary drug licensing team. Early phase trial support includes study design, protocol development, and population PK/PD modelling and simulation, backed by a bench of more than 70 statisticians, data managers and programmers. ECLIPTICA, its generative AI tool, produces synthetic datasets aimed at loosening data restrictions around orphan disease research, real-world evidence and market access. A partnership with giles applies an AI research agent to systematic literature reviews and to organising national data sources for indirect treatment comparisons, matching-adjusted indirect comparisons, and evidence synthesis for HTA submissions. R-S-S also teaches synthetic data generation through a one-day London course.

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