Regulatory Statistical Services

We are the regulatory statistical specialists in navigating your drugs and devices through the FDA and EMEA licensing process. R-S-S brings its years of experience from those who have had first-hand experience working in major health regulatory agencies (e.g. FDA, EMA, MHRA) to help solve the unique and complex challenges and requirements clients face throughout the clinical development process. Our team of statisticians provide excellent statistical services and consultancy across all phases of the clinical trial process. Our statisticians and programmers have experience in a multitude of therapeutic areas including more recent work on COVID-19. 

Our clients trust R-S-S to deliver on study design and analyses with speed and quality through years of training and experience. Our team have had great success rates in all projects undertaken by R-S-S and have supported clients on every step of their journey in project research, analyses, and project development. At R-S-S, we develop in house solutions such as sample size calculators to aid in study design for clients. We also provide expertise in HTA and reimbursement across multiple countries and therapeutic areas, helping our clients to design and develop trials for cost-effectiveness modelling and market access.  

Areas of Expertise

  • Regulatory Support

  • Briefing Books: FDA/EMA
  • EAMS
  • PIMS
  • PV – RMP
  • Inspection 
  • CDP
  • Protocol Design
  • Database Standardisation for FDA Submissions
  • Training & Courses
  • Drug & Device Licensing

  • SAP Writing
  • Pharmacokinetics & Pharmacodynamics
  • PK/PD Modelling
  • Statistical Methods

  • Adaptive Designs
  • Platform/Basket/Umbrella Designs
  • Bayesian Methods
  • Sample Size Calculations
  • Causal Analyses
  • SAP & Protocol Input
  • Bayesian Methods for HTA, Early & Late Development
  • Study Design
  • Programming Support

  • Innovative Programming Solutions
  • SAS & R Programming
  • CDISC Standards & Mapping
  • SDTM & ADaM Specifications & Data Sets
  • Real World Data/Registry Development 

 

We also offer tailor made training packages to professionals in industry. Please visit our training & courses page to learn more.

Do you have any questions about your clinical trial design, protocol, or data? Ask our experts for their input or guidance. We are happy to help.

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