• 2390 Faraday Ave, Carlsbad, CA 92008 USA
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Biostatistics and Statistical
Programming

Biostatistics

At RPM, we have expert biostatisticians team with specific therapeutic expertise and extensive regulatory knowledge that provide deliverables of high quality for clinical development plan and design, effective analysis and reporting and regulatory support that matches our clients' needs. Our biostatistics experts ensure uncompromised validation and accurate analysis of data with quality control processes to provide flexibility, speed and accuracy with trial reporting.


Our expert team of biostatisticians is proactively involved and informed throughout the trial phase. With years of experience in clinical trials and a strong analytical background, we are able to tackle various complex trials to meet our clients' desired expectations.





Our Biostatistics services include:


  • Efficient cost-saving clinical trial design
  • Protocol development
  • Statistical consulting
  • Sample size calculations
  • Inclusion/exclusion criteria
  • Study endpoints development
  • Randomization schedule/blinding/unblinding
  • Statistical input in study synopsis
  • Statistical analysis plan (SAP) development
  • Adaptive design and analysis
  • Patient profile reporting
  • Input in CRF/eCRF design
  • Integration of CDISC into entire study
  • Statistical Analysis and Report
  • Pharmacokinetic and pharmacodynamic analyses
  • Regulatory strategy for biostatistics
  • Regulatory submissions
  • Final Statistical Reports/Clinical Study Report
  • Integrated safety and efficacy analyses (ISS/ISE)
  • Data and safety monitoring board (DSMB) output
  • Blinded/unblinded interim analysis
  • Investigational new drug (IND) safety updates
  • Data Monitoring Committee (DMC) support
  • CDISC-compliant datasets (SDTM and AdaM) development and validation
  • Final data analysis
  • Data conversion and validation
  • Statistical analysis of clinical data and validation using SAS
  • Tailored statistical backing
  • Writing specifications document (SPD)
  • Creation and validation of tables, listings and figures for the Clinical Study Report (CSR) as per standard operating procedures (SOPs) to statistical input to the CSR
  • Independent quality assurance through external and internal consulting
  • Meta-Analysis
  • Collaboration with clinical scientists and medical writers to ensure significant analysis of quantitative results
  • Publication support

SAS Programming

The RPM SAS certified clinical programming team has the ability to turn inexplicable data into something significant in order to make informed decisions, demonstrate drug efficacy, improvement in patient safety and faster introduction of drugs to the market. Our programming expert team also has detailed knowledge of therapeutic areas and all phases of clinical trials.

Our SAS programming services include:


  • Clinical and statistical programming support
  • SAS programming compliant to CDISC/CDASH standards
  • Database Specification creation
  • CDISC standards: SDTM and ADaM, annotated CRF, define.xml file implementation and programming for regulatory submissions
  • Generating programming specifications for SDTM and ADaM datasets
  • Programming and validation of SDTM and ADaM datasets, tables, listings and figures
  • Custom Report Programming
  • Creation of Case Report Tabulations using CDISC standards
  • SAS Mapping Specification
  • SAS-Macros design, development and validation
  • Statistical Analysis Plan (SAP) and Mock-up Shells
  • Writing and maintaining specifications and SAS analysis programs based on SAP
  • Data Management Listings
  • SAS Edit Checks programming
  • Data Analysis and Report Generation
  • Statistical analysis validation
  • Creation of documentation for integrated databases
  • ISS and ISE programming support and quality control for ISR (Integrated Summary Report)
  • Statistical analysis modelling
  • Subject profiles and medical review listing programming
  • Study rescue and legacy data requests
  • Risk based validation, double-independent programming
  • Interim Analysis support
  • Statistical Meta-Analysis
  • Annual Safety Updates
  • Data Monitoring Committee (DMC),  Safety Committee  and Endpoint Committee Support
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