Clinical Research and Post Approval Services

Biostatistics, Statistical Programming and Consulting

Delivering high quality study designs, data and analysis in a timely and cost-effective manner

Sciformix delivers clinical biostatistics and statistical programming excellence across all phases of drug development in a wide range of therapeutic areas. Our biostatisticians and programmers have built a reputation of excellence by producing quality deliverables, maintaining the highest level of scientific integrity and being responsive, flexible and collaborative. Sciformix’s biostatisticians and programmers offer comprehensive services including:

  • Biostatistics
    • Input to Study Design (including adaptive designs) and sample size calculation
    • SAP, mock tables and LoT
    • Guidance to programmers and review of TLGs (tables, listings, graphs)
    • Statistical report and input to CSR
    • Response to requests and queries from regulators
    • Pharmacometric and Pharmacodynamic analysis and modeling
    • Interim analysis and support to data and safety monitoring boards (DSMBs)
    • Exploratory analyses for publications, abstracts, and marketing, including meta analysis
  • Statistical Programming
    • Inputs into statistical analysis plan and creations of mock shells
    • Develop Study Data Tabulation Model (SDTM) datasets and Analysis Data Model (ADaM) datasets and define.xml
    • Develop programming Specifications, analysis datasets and Tables, listings and figures (TLFs) for safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) endpoints
    • Programming support for Clinical Study Report (CSR), Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE) submissions and various other submissions during conduct of clinical trials
    • Ad-hoc programming for support of Statistics, Clinical Operations, Data Management and Regulatory functions
    • Develop Patient Profiles and In-text Tables
    • Support Interim analysis, Data Monitoring Committee meetings, Database lock related activities and regulatory submissions activities
    • Data conversion, migration, legacy to standard or SDTM mapping and conversion between different standards
    • Develop customized solutions for process standardization for clients and building standard macros as per client requirements
  • Consulting
    • Study Design across all phases of clinical trials, including interpretation of regulatory guidance, simulations for adaptive designs etc.
    • Participation on DSMBs and contribution to decision to stop or modify trials
    • Management of all biometrics aspects of clinical development programs all the way to regulatory filings, and management of rapid response as part of the regulatory approval process

Read more about our comprehensive Statistics, Programming and Consulting services.


Industry Best Practices – Quality Management System

Organizations who implement a comprehensive Quality Management System (QMS) that captures and analyzes metrics to provide insight into their operations can improve their quality and continually improve their processes for better outcomes.

When establishing a QMS for a programming department, it’s important to Classify and Categorize metrics appropriately, along with establishing processes and oversight to facilitate continuous improvement.

Download our whitepaper on QMS Best Practices. (PDF)