The drug approval process by various regulatory authorities around the world involves significant analysis and data representation of clinical data. These aspects are managed by biostatisticians and statistical programmers along with data scientists. At Sumptuous Data Sciences we are focused on offering these services through the business model suitable to our clients. The business models we are operating includes the staffing as well as project- based consulting models. Our staff is highly experienced in all major therapeutic disciplines and have supported numerous drug submissions for various regulatory authorities around the world. See more details in services offering below.-

  • CRF and protocol Reviews
  • Development of statistical analysis plan
  • Review of clinical data presentations
  • Statistical surveillance and monitoring
  • Pooled data analysis
  • Statistical report writing
  • Conducting interim analysis
  • Data safety reviews
  • Regulatory submission support
Healthcare and clinical data analysis
  • Structured Data Collection and Healthcare data modelling.
  • Implementation of FHIR-HL7 and OMOP-CDM.
  • Research design and development of statistical methods
  • Statistical analysis of out- patient delivery data
  • Data Anonymization Processes
  • PKPD Modelling, analysis and reporting.
Statistical Programming and Data Sciences
  • Development of statistical mock table presentations
  • Data transformations and mapping
  • Production of tables, listings, graphs and profiles
  • Electronic submission data processes
  • Risk based monitoring
  • Edit check programming
  • Data integrity checks and custom report generation
  • Clinical data monitoring, reconciliation and integrity checks
  • Pooled data analysis and tabulations
Data standards Governance and Application
  • Development of data standards: CDISC SDTM, ADAM and TLF generation
  • Application of data standards to healthcare and clinical data
  • Development of data transformation methods
  • Validation of transformed data
  • Application of industry data standards
  • Data standards compliance required for regulatory submissions
  • Maintenance of clinical data standards
  • Development of Custom TLF Reporting
Strategic Consulting
  • Clinical data operations process planning and development
  • Development and review of standard operating procedures, guidance and work instructions
  • Technology due diligence
  • Regulatory submissions consultation