Sample Size Calculation AI Tool
Let your AI agent handle complex sample size calculations for clinical research—instantly delivering results, assumptions, and ready-to-use justification text for protocols.
You spend hours in Excel and R, double-checking formulas and updating sample size estimates every time a protocol changes. As a clinical biostatistician, you risk errors that can delay regulatory submissions or force costly amendments. Tracking assumptions and writing justification text for each scenario eats up valuable analysis time.
An AI agent that calculates sample sizes for clinical trials, generates documentation, and provides audit-ready justification for biostatisticians.
What this replaces
The hidden cost
What this is really costing you
In pharmaceutical and CRO environments, biostatisticians must calculate and document sample sizes for every clinical trial design. This means pulling parameters from Medidata or REDCap, updating spreadsheets, and manually drafting rationale for each protocol version. Every amendment triggers a cascade of recalculations and edits—often under tight timelines and regulatory pressure. The risk of error or missing documentation is high, especially when juggling multiple studies.
Time wasted
2 hrs/week
Every week, burned on work an AI agent handles in minutes.
Money lost
$4,700/year
In salary, missed revenue, and operational drag — annually.
If you keep ignoring it
Missed errors in sample size calculations can result in underpowered studies, FDA or EMA submission delays, and expensive protocol amendments.
Cost estimates derived from U.S. Bureau of Labor Statistics occupational wage data and O*NET task analysis.
Return on investment
The math speaks for itself
Today — without agent
2 hrs/week
of manual work
With your AI agent
20 min/week
agent-handled
You save
$3,920/year
every year, reinvested into growing your business
Estimates based on U.S. Bureau of Labor Statistics median salary data and O*NET task importance ratings from worker surveys. Time savings assume 80% automation of eligible task components.
Jobs your agent handles
What this agent does for you
Complete jobs, handled end-to-end — so your team focuses on what matters.
Quick Calculation for New Study
You ask your agent to calculate the sample size for a two-arm superiority trial with 80% power and a 5% significance level.
Protocol Amendment Support
You ask your agent to recalculate sample size after a protocol change affecting the primary endpoint.
Regulatory Submission Prep
You ask your agent to generate a justification summary and assumptions table for inclusion in your protocol document.
Scenario Planning
You ask your agent to compare sample size requirements for varying dropout rates and effect sizes to inform study design decisions.
How to hire your agent
Connect your tools
Link your existing data analysis, clinical trials database, and documentation tools used for protocol development and statistical planning.
Tell your agent what you need
Type: 'Calculate the sample size for a three-arm non-inferiority trial with 90% power, 2% significance, and expected dropout rate of 10%.'
Agent gets it done
Receive a precise sample size calculation, a summary of assumptions, and ready-to-use justification text for your protocol or report.
You doing it vs. your agent doing it
Agent skill set
What this agent knows how to do
Automated Clinical Trial Calculations
Calculates sample sizes for superiority, non-inferiority, and stratified designs using parameters from REDCap or Medidata.
Dynamic Protocol Adjustment
Updates calculations and documentation instantly when you modify endpoints or effect sizes in your trial design.
Assumptions Tracking
Generates a detailed table of all statistical assumptions and parameters, ready for inclusion in protocol documents.
Justification Drafting
Writes clear, audit-ready rationale text for sample size sections in protocols and statistical analysis plans.
Scenario Analysis
Compares sample size requirements across multiple dropout rates or effect sizes, presenting results in a formatted table.
AI Agent FAQ
The AI agent applies validated statistical formulas and cross-checks each calculation against your specified parameters. You can review all outputs, including the full assumptions table, before using results in your protocol.
Your agent handles common clinical trial designs such as superiority, non-inferiority, multi-arm, and stratified studies. For highly customized or adaptive designs, you can review and adjust the agent's output as needed.
Yes, the agent generates audit-ready calculation summaries and justification text tailored for inclusion in regulatory documents. You should review and finalize the text to match your submission format.
Currently, you manually input study parameters from Medidata, REDCap, or other EDC systems. Automated integration is planned for future updates.
The agent is optimized for standard clinical trial designs and English-language documentation. For highly novel study types or non-English protocols, manual review is recommended.
Related tasks
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