Our Services

Specialized statistical consulting for pharmaceutical and biotech companies, with services spanning clinical trial design, data analysis, and regulatory submission support. Expertise includes biostatistics, statistical programming, and compliance with global regulatory standards. Whether assisting with protocol development, SAPs, or submission deliverables, the focus is on delivering tailored, high-quality solutions that support successful and efficient drug development.

Biostatistical Consulting

Ensure the statistical integrity and scientific validity of your clinical trials from start to finish.
Services include:

  • Clinical Trial Design: Support for Phase I–IV trials, including endpoint selection, randomization schemes, and study objective alignment.

  • Sample Size & Power Calculations: Ensuring trials are adequately powered for statistical and regulatory standards.

  • Statistical Analysis Plans (SAP): Development or review of detailed SAPs aligned with regulatory requirements and study goals.

  • Interim Monitoring Support: Design and analysis planning for interim reviews, including DSMB interactions.

Regulatory Support

Navigate the complex regulatory landscape with clarity and confidence.
Services include:

  • Regulatory Submission Prep: Statistical content development for FDA/EMA submissions, including BLA, NDA, and IND filings.

  • ISS/ISE Reports: Integrated summaries of safety (ISS) and efficacy (ISE) aligned with guidance from ICH E3 and FDA.

  • CDISC Compliance: Mapping and validation of datasets (SDTM, ADaM) for regulatory-ready formats.

  • Meeting Support: Preparation for regulatory meetings (Type B/C), including statistical briefing documents and slide decks.

Study Design Consulting

Design smarter, more efficient trials that align with scientific and commercial goals.
Services include:

  • Adaptive Design Strategy: Planning for dose escalation, sample re-estimation, and other adaptive features.

  • Bayesian Approaches: Implementation of Bayesian methods for prior-informed or predictive modeling.

  • Innovative Trial Designs: Support for umbrella, basket, platform, or decentralized trials.

  • Simulation-Based Planning: Using Monte Carlo or other simulation tools to assess design performance.

Data Analysis & Reporting

Turn complex datasets into meaningful insights and submission-ready results.
Services include:

  • Statistical Programming: Expert programming in SAS, R, and other tools to execute analyses efficiently and reproducibly.

  • Data Cleaning & QC: Ensuring dataset integrity through exploratory analysis and validation procedures.

  • Tables, Listings, and Figures (TLFs): Creation and review of high-quality, publication-ready outputs.

  • Interim & Final Study Reports: End-to-end support for CSR statistical sections, including appendices and reviewer guides.

Protocol & SAP Review

Ensure alignment between your protocol and statistical deliverables.
Services include:

  • Protocol Review: Evaluation of statistical methodology, endpoints, and feasibility from a regulatory and scientific standpoint.

  • SAP Refinement: Enhancement of existing SAPs for clarity, reproducibility, and completeness.

  • Cross-Functional Collaboration: Working with clinicians, data managers, and medical writers to ensure statistical accuracy throughout trial documentation.