Analyze.

We deliver trusted, submission-grade analyses using validated methods and robust statistical techniques. Every dataset and model is optimized to maximize insight, demonstrate efficacy, and support claims in alignment with FDA and global regulatory standards.

Submission-Grade Statistical Analyses

That Stand Up to Scrutiny

We deliver trusted, submission-grade analyses using validated methods and robust statistical techniques. Every dataset and model is optimized to maximize insight, demonstrate efficacy, and support claims in alignment with FDA and global regulatory standards.

When it comes to regulatory submissions, data is only as strong as the integrity of the analysis behind it. At BSC, we deliver fully validated, submission-grade statistical analyses that provide credible and actionable evidence of safety and efficacy. Our team is fluent in the statistical methodologies required by the FDA, EMA, and other global regulators, and we are known for precision, transparency, and responsiveness under the tight deadlines of regulatory review.

Every dataset we analyze is subject to rigorous quality control and reproducibility standards. From protocol-defined endpoints to exploratory analyses, we employ frequentist and Bayesian techniques, model-based estimation, imputation strategies, subgroup assessments, and advanced visualization to illuminate key findings and uncover hidden patterns. All statistical programming is performed using validated SAS and R scripts in 21 CFR Part 11-compliant environments, ensuring traceability and audit readiness.

We don’t just run models — we challenge assumptions, verify inputs, and ensure every conclusion drawn from the data is statistically defensible. Our goal is to ensure that the final analysis package not only meets regulatory standards but exceeds expectations in clarity, precision, and scientific rigor.

Statistical Programming.

General statistical programming

Implementation of statistical methods

Table Shells Programming

Statistical screening of data

Protocol Violation Phase

Unblinding

Documentation

Consultations

Statistical Analysis.

  • Statistical analysis of data

  • Statistical Analysis/Modeling

  • Statistical assessment of protocol violations

  • Interim analyses

  • Additional analysis request not in the data analysis plan

  • Statistical review of programmer/analyst analyses

  • Other statistical analysis

Clinical Study Statistical Reports.

  • Tables / Listings / Figures (TLFs)

  • Methods, results, and analysis synopsis

  • Clinical Study Report production

Why do we focus on these core services?

Statistical analysis is where the credibility of a trial is won or lost. Every number in a clinical study report — from primary endpoint p-values to exploratory trends — is the result of a sequence of analytical decisions. Our core analysis services are built to ensure those decisions are scientifically sound, transparent, and regulatory-ready. We focus on these services to:

  • Deliver valid, defensible conclusions by applying statistical methods that match the trial design, data structure, and endpoint characteristics, minimizing the risk of overstating results or drawing unsupported inferences.

  • Preserve trust and transparency with a clear audit trail from raw data to final figures, enabling reproducibility and regulatory confidence at every step.

  • Respond efficiently to evolving questions through flexible yet controlled analytical frameworks that allow for post hoc exploration, subgroup insights, and sensitivity assessments without compromising integrity.

  • Support robust decision-making by presenting results in formats tailored to stakeholders, whether it’s a DSMB reviewing interim safety trends or a sponsor preparing for FDA submission.

  • Integrate seamlessly across functions by aligning statistical logic with programming workflows, clinical narratives, and regulatory expectations.

The result: analyses that don’t just “run” — they inform, persuade, and withstand scrutiny.

Case Studies.