Statistical Programming

Standardized Data (SDTM)

Regulatory submissions and data integration require a standardized approach.
Our experts assist in converting clinical data into CDISC SDTM (Study Data Tabulation Model) format or other customer-specific formats, ensuring compliance and consistency.

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Regulatory-Compliant Data Formatting

Converting raw data into submission-ready formats.

CDISC SDTM Expertise

Aligning study data with latest industry standards.

Seamless Integration

Supporting interoperability with data warehouses and regulatory systems.

Analysis Data (ADaM)

To generate accurate analysis outputs, data must be properly formatted and structured. Our Statistical Programming team ensures compliance with CDISC ADaM (Analysis Data Model) standards for regulatory submission and clinical data analysis.

Accurate Data Structuring

Preparing datasets for effective statistical analysis.

Regulatory-Ready ADaM Datasets

Ensuring compliance with submission requirements.

Efficient SDTM-to-ADaM mapping

Supporting consistency across datasets.

Analysis Outputs (TFLs)

Tables, Figures, and Listings (TFLs) are critical for clinical trial analysis.
Our programmers manage analysis requirements, track progress, and collaborate with biostatisticians to ensure high-quality output.

Comprehensive  Statistical Outputs

Generating high-quality Tables, Figures, and Listings.

Collaboration with Biostatistics Teams

Ensuring alignment with Statistical Analysis Plans. 

Regulatory Submission Readiness

Reliable Outputs, ensuring traceability from final results back to SDTM.

Regulatory Submissions & Data Integration

Bioforum has a proven track record of over 25 successful regulatory submissions, ensuring data integrity and compliance with global standards.

Integrated Summary of Safety (ISS) & Efficacy (ISE)

Supporting regulatory review processes.

Legacy Study Submissions

Converting and integrating historical study data Into CDISC standards for the submission..

Independent Quality Review

Ensuring compliance accuracy of SDTM, ADaM, and TFL deliverables.

Regulatory Biostatistics Support

Strategic input for FDA/EMA meetings and submissions

The Bioforum Advantage

Bioforum delivers expert statistical programming to ensure your clinical trials are accurate, compliant, and efficient. Our experienced team brings deep technical knowledge and proven success across all phases of development.

Customized Solutions

Tailored statistical strategies to fit your study’s needs.

Regulatory Excellence

Ensuring compliance with global standards.

Seamless Collaboration

Aligning with clinical, medical writing, and data teams.

Partner with Bioforum for data-driven insights that drive smarter clinical decisions.

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Statistical Programming FAQs

Why are both SDTM and ADaM needed?

SDTM organizes collected data into standardized tabulation domains, showing reviewers what was observed. ADaM structures analysis-ready data and preserves links among source observations, derived variables, analysis populations and results. A strong CDISC package includes consistent metadata, documented derivations, controlled terminology and traceability aligned to the protocol and statistical analysis plan.

How long does a first SDTM delivery typically take?

Bioforum’s average time to first SDTM delivery is three weeks. Timelines depend on data complexity and specification stability, but automation removes most manual mapping effort. JetConvert uses machine learning rather than SAS programming, combining AI-guided mapping recommendations, a reusable metadata library across studies, and automatic annotated CRF and Define generation.

How is traceability maintained from source data to TFLs?

Traceability is built through aligned specifications, metadata, derivation documentation and controlled programming workflows. Every value in a table, figure or listing should be explainable through the analysis datasets and linked back to SDTM or source data. Bioforum maintains source-to-SDTM and SDTM-to-source traceability, with sponsor access to the mapping review module so conversion logic and progress stay visible throughout.

How can sponsors validate CDISC compliance before submission?

Compliance should be checked continuously rather than once at the end. Bioforum offers SUBMIT24, a free validator built on CDISC CORE that any sponsor can use to check datasets against published conformance rules. It also generates Define.xml, annotated CRFs and reviewers’ guides. Running validation early surfaces structural and terminology issues while they remain inexpensive to fix.

Standardized Data (SDTM)