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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.

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
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

Bioforum offers end-to-end biostatistical and statistical programming services. This includes assistance with study design, writing the Statistical Analysis Plan, receiving raw data from Data Management and other vendors, converting to standard and analysis data formats such as SDTM and ADaM, generating analysis outputs (Tables, Listings & Figures) and authoring the statistical section of the CSR. Bioforum can also help you with data conversion to other data standards, legacy study support, statistical analysis, data integrations (ISS\ISE), DMC\DSMB report and unblinded support and independent quality review.

As a mid-size CRO, we are big enough to cover all your biostatistics and statistical programming needs, and small enough to ensure that all our projects are being managed effectively, regardless of size or scope. With a customer base including pharma, academia and non-profit, CROs and EDC companies, the broad spectrum of clinical research sectors, combined with experience in a variety of therapeutic areas over all study phases, promotes skill development in all areas of statistical programming. Our innovative culture is showcased by the recent launch of our JetConvertTM technology, an SDTM conversion tool that uses machine learning with no SAS involved, resulting in significant reduction of effort required to produce SDTM datasets of superior quality.

Through our independent Quality Assurance (QA) department and quality management system, we ensure that both processes and deliverables meet the industry standards and customer requirements. We leverage internal processes like quarterly internal audits, periodic review of controlled documents, continuous training, individual development plans, continuous process improvement, timely and thorough action on deviations, audit findings, customer complaints and CAPAs to maintain our reputation for quality. We are also ISO 9001:2015 certified.

Bioforum has experience in many different therapeutic areas. These include (in descending order of experience): oncology, neurology, psychiatry, cardiology, orthopedics, dermatology, gastroenterology, ophthalmology, gynecology, and immunology. This list is not exhaustive—we listed here just the top 10, and there are many more in which we have experience.

Learn more about our services