Statistical Programming Services

Our statistical programming experts provide comprehensive biostatistical programming support spanning clinical trials, non-clinical studies, and research across all stages of drug development. We offer a wide array of services leveraging industry-leading software and adhering to CDISC standards.

Data Standardization & Mapping:
  • Transforming raw study data into CDISC SDTM or SEND formats
  • Generating analysis-ready datasets (ADaM) from SDTM or raw data sources
  • Creating high-quality Define-XML files (including Analysis Result Metadata), reviewer’s guides, and other supporting documentation
  • Ensuring conformance and compliance with requirements across different regulatory authorities
Data Analysis:
  • Our professional programmers develop and finalize data listings, tables, and graphical representations to facilitate analysis and reporting
  • Adhering to FDA, ICH, and other relevant regulatory guidelines
  • Automating reporting processes for efficiency
  • Supporting interactive data visualizations, dashboards, and analytics using tools like RShiny, PowerBI, SpotFire, and others
  • Seamless integration of data source, data clean, data analysis and reports by using APIs and other data connectors
Regulatory Expertise & Tailored Solutions:
  • Our team has extensive experience preparing submission-ready deliverables that meet rigorous standards across global health authorities, including FDA (CDER, CBER), EMA, PMDA (Japan), NMPA (China), and other major regulatory authorities
  • Ensuring meticulous adherence to the latest regulatory guidelines, data standards, and requirements
  • Well-versed in the nuances of different submission types (e.g., NDAs, BLAs) and therapeutic areas
  • Leveraging cutting-edge tools and technologies to optimize programming efficiency while maintaining the highest quality standards
  • Preparing submission packages simultaneously for multiple regulatory authorities

We have extensive experience across all major therapeutic areas and all phases of clinical development. Our statistical programmers combine domain expertise with proficiency in SAS, R, Python and other tools to deliver high-quality regulatory submissions.

Strategic consultants are available to advise on data standards, process implementation and submission strategies. We take a collaborative approach, integrating with biostatistics and clinical teams to drive successful study execution.

Flexible, Scalable, and Cost-Effective FSP Model

We recognize that clinical development programs have dynamic resource requirements that can fluctuate over time. Our Functional Service Provider (FSP) model for statistical programming offers a flexible, scalable, and cost-effective resourcing solution.

  • Flexibility
    • Our FSP enables you to rapidly adjust your statistical programming team size and skill mix as your project needs evolve. We can accommodate headcount-based or hours-based models, allowing you to match resourcing precisely to your evolving needs.
    • We can seamlessly integrate with your standards, processes, and tools, ensuring a cohesive collaboration with your existing systems and study teams.
  • Scalability
    • With a centralized pool of statistical programming experts, we can scale resources up or down effortlessly across multiple projects or indications. Whether you require a few programmers or a large team, we have the capacity to meet your requirements without compromising quality or timelines.
    • We have over 400 in-house programmers across 16 offices in 9 countries. We can provide support through our in-house resources or quickly ramp up by tapping into the market.
  • Cost-Effectiveness
    • Our FSP pricing model is designed to optimize spending across your entire program. You only pay for the specific resources utilized, with no inflated overhead or markup. Consolidated FSP pricing leads to significant cost savings compared to individual contractor rates or other resourcing models.
    • We have resources proficient in English and Japanese, enabling us to optimize cost by adjusting the resource ratio across different regions.

With our extensive experience supporting clinical development, we understand the importance of predictable budgets and expenditure. Our FSP model enables more accurate forecasting of programming costs across your entire portfolio.

Whether supplementing an existing team or seeking a fully outsourced solution, our FSP model delivers the statistical programming resources you need through a flexible, scalable, and cost-effective approach.