Biometrics & Clinical Data
Statistical Rigor and Clean Data Pipelines
that Accelerate Clinical Success
REV Clinical’s biostatistics and clinical data management team provides critical, interlocking expertise across these areas to inform study design, support execution excellence, deliver valuable clinical analyses, and support successful regulatory filings.
Biometrics Driving
Decision Making
From study design exploration to final regulatory submissions, REV’s biometrics team designs smarter studies, transforms raw signals into approval-ready insights, and equips sponsors with analyses that accelerate filings.
01
& Design
Our biostatistical experts guide adaptive study design by defining hypotheses and endpoints, selecting models, and conducting robust power analyses to determine the necessary sample sizes for sufficient statistical certainty, managing bias, and quantifying uncertainty.
02
Analysis
Not only does the data need to be organized, but it also needs to be analyzed to draw insights that could prove or disprove a particular medical hypothesis. Our biostatisticians turn raw trial data into interpretable evidence via inference and reproducible workflows that support safety, efficacy, and sound regulatory decisions.
03
Decision Making
Biostatistics tools rapidly organize massive datasets by cleaning and normalizing inputs, structuring variables, and automating pipelines. Techniques such as clustering, stratification, and dimensionality reduction reveal patterns, while dashboards and queryable tables facilitate filtering, prioritization, and reproducible analyses that inform evidence-based decisions.
04
Integration & Submission
Biostatistics underpins submissions by planning analyses, standardizing datasets, and generating validated outputs. As just a few examples, for Clinical Study Reports (CSRs) it drives methods and results; for Integrated Summary of Safety / Efficacy (ISS / ISE) it harmonizes studies and integrates safety/efficacy; for Development Safety Update Report (DSUR) it compiles cumulative exposure, detects signals, and quantifies benefit–risk—ensuring regulator-ready evidence.
Strengthen Your
Submissions
REV’s clinical data management team turns raw trial data into submission-ready evidence. Our team has experience with multiple EDC platforms and is comfortable using sponsor-preferred EDC platforms. We design eCRFs and edit checks, deploy platform-agnostic, 21 CFR Part 11/ICH-GCP–compliant electronic data capture (EDC), and manage clean data flows from sites, labs, and electronic patient-reported outcomes.
Our team executes robust data validation plans, medical coding, serious adverse event (SAE) reconciliation, query management, and blinded data reviews supporting centralized/risk-based monitoring.
- Adhere to data standards of global regulatory bodies
- Preserve full audit trails
- Accelerate production of tables, listings, and figures (TLF)-ready data sets
- Ensure consistency, reproducibility, and reviewer clarity for CSR, ISS, and ISE deliverables
With real-time dashboards and disciplined governance, REV Clinical achieves faster database locks, fewer surprises, and regulator-ready integrity across early- and mid-phase studies
Let’s Move Your Study Forward
Interested in connecting with REV Clinical’s team of interdisciplinary experts to answer questions, take action on your RFP, and clearly define next steps?