Statistical & Programming Solutions
At R-S-S, we provide a comprehensive suite of biostatistical services, tailored to your needs, with a commitment to excellence and cutting-edge statistical solutions.
Regulatory Expertise
We are the regulatory statistical specialists – navigating your drugs and devices through the regulatory process. The R-S-S team draws its expertise from years of first-hand experience working in major health regulatory agencies (e.g. FDA, EMA, MHRA) to help solve the unique and complex challenges clients face throughout the clinical development journey.
Setting the Standard in Excellence & Value
At R-S-S, we are committed to offering a comprehensive suite of biostatistical consultancy services to suit your needs. Our flexible and collaborative working approach provides you with access to a robust network of industry experts that can support you every step of the way. We support our clients by providing tailored biostatistical and programming services. We pride ourselves on timely and high-quality delivery of services, and on being a non-transactional service provider.
Our Services
- Study Design & Set-Up
- PK/PD Modelling & Simulation
- Statistical Programming, Analyses & Reporting
- Health Technology Assessment
- Health Economics & Evidence Synthesis
Study Design & Set-Up
- Study Design
- Adaptive and Bayesian Methods
- Platform/Umbrella/Basket Designs
- Sample Size Calculations
- Simulations
- Protocol Development
- Randomization
PK/PD Modelling & Simulation
- Bioavailability and Bioequivalence Studies
- Drug Interaction Studies
- Food Effect Studies
- Dose Proportionality Assessment
- Phase I Dose Escalation Studies
- Pop PK Model Development
- Pop PK/PD Model Development
- Physiologically based PK/PD Models (PBPK/PD)
- Dose Response Modelling
- Model-Based Drug Development
- Simulations for Dose Optimisation
- Biomarker Identification and Validation
- Preparation and Submission of PK/PD Reports
- Models for Regulatory Authorities
Statistical Programming, Analyses & Reporting
- Statistical Analysis Plans
- Statistical Analyses & Modelling
- Bayesian Methods for Early & Late Development
- PK/PD Modelling & Analyses
- Clinical Study Reports
- SAS & R Programming
- SDTM & ADAM Specifications and Datasets
Health Technology Assessment
- Statistical Analysis of Study Data
- Bayesian Methods for NMA
- Indirect Treatment comparisons
- Analyses of Surrogate Endpoints
- Survival Extrapolation
- Analyses of PROs & HRQoL Outcomes
Health Economics & Evidence Synthesis
- Economic Model Strategy & Design
- Health Economic Modelling
- Cost-Effectiveness Modelling
- Health Policy Modelling
- Budget Impact Modelling
- Clinical Trial Design for Reimbursement
Study Design & Set-Up
Study Design & Set-Up
- Study Design
- Adaptive and Bayesian Methods
- Platform/Umbrella/Basket Designs
- Sample Size Calculations
- Simulations
- Protocol Development
- Randomization
PK/PD Modelling & Simulation
PK/PD Modelling & Simulation
- Bioavailability and Bioequivalence Studies
- Drug Interaction Studies
- Food Effect Studies
- Dose Proportionality Assessment
- Phase I Dose Escalation Studies
- Pop PK Model Development
- Pop PK/PD Model Development
- Physiologically based PK/PD Models (PBPK/PD)
- Dose Response Modelling
- Model-Based Drug Development
- Simulations for Dose Optimisation
- Biomarker Identification and Validation
- Preparation and Submission of PK/PD Reports
- Models for Regulatory Authorities
Statistical Programming, Analyses & Reporting
Statistical Programming, Analyses & Reporting
- Statistical Analysis Plans
- Statistical Analyses & Modelling
- Bayesian Methods for Early & Late Development
- PK/PD Modelling & Analyses
- Clinical Study Reports
- SAS & R Programming
- SDTM & ADAM Specifications and Datasets
Health Technology Assessment
Health Technology Assessment
- Statistical Analysis of Study Data
- Bayesian Methods for NMA
- Indirect Treatment comparisons
- Analyses of Surrogate Endpoints
- Survival Extrapolation
- Analyses of PROs & HRQoL Outcomes
Health Economics & Evidence Synthesis
Health Economics & Evidence Synthesis
- Economic Model Strategy & Design
- Health Economic Modelling
- Cost-Effectiveness Modelling
- Health Policy Modelling
- Budget Impact Modelling
- Clinical Trial Design for Reimbursement