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Precision, Compliance, and Efficiency in Clinical Data

Statistical Programming
We ensure accurate, compliant, and seamlessly integrated statistical programming to support clinical trials from design to submission—helping clients standardize data, meet regulations, and accelerate timelines.

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.

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.

Regulatory Biostatistics Support

Strategic input for FDA/EMA meetings and submissions

Analysis Data (ADaM)

To generate accurate analysis outputs, data must be properly formatted and structured. Our 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.

Seamless Transition from SDTM to ADaM

Supporting consistency across datasets.

Regulatory Biostatistics Support

Strategic input for FDA/EMA meetings and submissions

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
Comprehensive 
Statistical Outputs
Generating high-quality Tables, Figures, and Listings.
Collaboration with Biostatistics Teams
Collaboration with Biostatistics Teams
Ensuring alignment with Statistical Analysis Plans.

Regulatory Submission Readiness
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.

Frequently Asked Questions

Our medical writers have experience in a wide variety of therapeutic areas including Neurology, Oncology, Infectious Diseases, Immunology, Genetics, Computational Biology/Bioinformatics, Pharmacology, Hematology, Drug Development, (AI-based) Medical Devices and Molecular Diagnostics.

The amount of time to complete a writing project varies significantly between projects. The complexity of the studies and the development program are the primary factors in determining the time to completion of a writing project. A few additional factors are the amount of literature searching that is required (i.e., if the Sponsor can provide a literature collection, this would be a good way to accelerate the writing process), the clarity of messaging (i.e., the clearer we are on expectations at the outset, the faster we can write) and availability of reviewers to provide input on the delivered drafts. We discuss the timeline in the kickoff meeting and assign two writers per project, to increase writer availability and allow for concurrent work, where applicable.

We prepare a unique proposal for each project. Our unit of pricing is hour of work and our basic process comprises a shell document, three full drafts, quality checking and publishing. The effort estimation includes internal review and oversight by a team leader. We also offer a timed contract model, in which a writer is fully dedicated to a client and can work on multiple projects. This model is offered on a full- or half-time employee (FTE) basis, for 3-, 6- or 12-month contracts. This model also includes support from MW team leaders.

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