FSP Services
R-Based Delivery Model
Scalable, Embedded R Expertise for Modern Clinical Data Analytics
Our Functional Service Provider (FSP) offers sponsors with dedicated, embedded statistical and programming resources specializing in R-based clinical trial analytics. Designed for flexibility and scalability, our FSP model integrates seamlessly into sponsor teams, enabling consistent delivery, faster execution, and predictable resourcing, while maintaining full regulatory compliance.
We support sponsors transitioning from traditional SAS-centric workflows to modern, R-driven analytics or operating hybrid SAS–R environments without disrupting ongoing programs.
Dedicated, Embedded Teams
Under the FSP model, we provide dedicated biostatisticians and statistical programmers trained in R, with sufficient knowledge of SAS, for modern clinical data analytics, seamless integration with sponsor SOPs, standards, and governance, and flexible scaling to support workload variability. Our teams function as an extension of your organization, not as an external vendor.
Experience
Our team members have extensive experience in statistical and programming services using R, including: SDTM and ADaM development (R-native or hybrid workflows), Statistical analysis and TLF generation, SAP development and implementation, DMC data preparation and ongoing analysis, and CSR and topline report support. All R-based work is performed within our Compliant R Environment (CRE) or your compliant environment, ensuring reproducibility, traceability, access control, and audit readiness.
RShiny and Automation Development
Our R-based FSP teams have extensive experience in developing Shiny apps and automation tools to improve efficiency and quality: Reusable R modules, functions, and applications that support interactive review at both patient and group levels, LLM-based R Shiny chatbot for on-demand information querying and retrieval, standardized analysis pipelines, automated generation of tables, listings, figures, and report-ready outputs, and reduced timelines from database lock to delivery. This approach minimizes manual effort while improving consistency across studies and programs.
Regulatory-Ready Delivery
Our statisticians and programmers bring extensive experience supporting global regulatory submissions. We understand the regulatory scrutiny applied to open-source tools and design our FSP delivery accordingly.
Our mission is to help sponsors operate modern analytics on a scale, without compromising compliance or control.
Let’s Connect
If you are interested in learning how our R-based Functional Service Provider (FSP) model can support your clinical development programs, we would be happy to discuss your needs and explore a tailored engagement.
