Statistical Services

Statistical expertise for clinical development

From protocol design to regulatory submission, our biostatisticians partner with sponsors to design better studies, navigate regulatory complexity, and apply continuous analysis where it creates value.

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How we engage

Statistical support at every level

No two development programs require the same statistical support. We provide flexible engagement models, from targeted consulting and study-level deliverables to comprehensive statistical leadership across an entire clinical program.

We work to ICH E9 and E9(R1) for design and estimands, ICH E3 for reporting, and CDISC standards for data and documentation.

Design

Study design

Get the design right before a single patient is enrolled.

Sound trials begin with sound design. We work with clinical teams to define the estimands under ICH E9(R1), then build strategies that can answer them. That means sample size and power calculations with their assumptions stated openly, randomization and stratification suited to the population, and adaptive elements pre-specified with established, operating characteristics.

Capabilities

Estimand frameworkSample sizeRandomizationAdaptive designPre-specification

Planning

Statistical Analysis Plan

An SAP written for your trial, not filled in from a template.

Our SAP authoring service goes beyond template completion. We specify the analysis populations, estimands, multiplicity strategy and handling of missing data your protocol actually requires, and build in our novel, continuous Pre.sentient approaches to maximize your trial resources.

Capabilities

SAP authoringMultiplicityMissing dataSensitivity analyses

Conduct

DMC and interim support

Independent oversight, supported without breaking the blind.

We provide fully firewalled continuous analysis execution, through the Pre.sentient platform, for Data Monitoring Committees, with strict information barrier protocols that maintain trial integrity. Our biostatisticians prepare open and closed reports, support the DMC's ongoing data review, and provide the summaries that it needs to meet charter obligations.

Capabilities

Firewalled interim analysisDMC reportsOngoing data reviewCharter support

Analysis

Statistical programming

CDISC-compliant datasets and outputs, quality controlled throughout.

We produce CDISC-compliant SDTM and ADaM datasets alongside complete TLF packages. All outputs are independently quality controlled, with Define-XML documentation accompanying every deliverable. Programming runs continuously throughout the trial, allowing for outputs while decisions are still being made.

Deliverables

SDTMADaMTLF productionQC / double programmingDefine.xml

Submission

Clinical Study Report

The statistical case for your submission, and the answers after it.

We author the statistical sections of your CSR to ICH E3 standards and provide integrated summaries of efficacy and safety for NDA, BLA, and MAA submissions. Where queries arise post-submission, our biostatisticians provide precise responses, drawing on direct familiarity with the study data and analytical decisions made throughout the trial.

Deliverables

CSR statistical sectionsISE / ISSRegulatory queries

Start with a conversation

Talk directly with a biostatistician about your program, your challenges, and where Pre.sentient can add value.

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