AI Tool for Protocol Review
Let your AI agent handle the heavy lifting of analyzing research protocols and suggesting appropriate statistical methods, so you can focus on higher-level insights.
You spend hours each week combing through lengthy clinical protocols in Microsoft Word and Excel, cross-referencing analysis plans, and documenting every decision. As a biostatistician, manually matching study designs to statistical methods is tedious and mentally exhausting. Important deadlines slip when you’re buried in repetitive review work.
An AI agent that reviews clinical research protocols, recommends statistical analyses, and drafts rationale text for biostatistics teams.
What this replaces
The hidden cost
What this is really costing you
In pharmaceutical and medical research, biostatisticians are routinely tasked with reviewing complex clinical trial protocols. This means pulling up protocols from SharePoint, extracting study design details, and drafting justification text for every statistical method used. The process is repetitive, prone to oversight, and eats into time that could be spent on deeper data analysis or collaborating with clinical teams.
Time wasted
1.8 hrs/week
Every week, burned on work an AI agent handles in minutes.
Money lost
$2,610/year
In salary, missed revenue, and operational drag — annually.
If you keep ignoring it
Missed deadlines for IRB submissions, inconsistent recommendations in protocol documents, and increased risk of costly revisions when errors slip through manual review.
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
1.8 hrs/week
of manual work
With your AI agent
15 min/week
agent-handled
You save
$2,030/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.
Assessing a New Clinical Trial Protocol
You ask your agent to review a new oncology trial protocol and recommend statistical methods for primary and secondary endpoints.
Comparing Analysis Approaches
You ask your agent to evaluate two proposed study designs and suggest the best statistical approach for each.
Documenting Review Decisions
You ask your agent to generate a rationale explaining why a mixed-model analysis was selected for a crossover study.
Preparing for IRB Submission
You ask your agent to summarize protocol analysis decisions for inclusion in an IRB submission package.
How to hire your agent
Connect your tools
Connect your existing tools for protocol documents, data files, and statistical analysis notes.
Tell your agent what you need
Type: 'Review this cardiac study protocol and recommend the best statistical analyses for each endpoint.'
Agent gets it done
Receive a structured report with extracted protocol details, recommended statistical methods, and ready-to-use rationale text.
You doing it vs. your agent doing it
Agent skill set
What this agent knows how to do
Extract Study Design Elements
Pulls key design details from uploaded protocols (PDF or Word) and organizes them into a structured summary for review.
Recommend Statistical Analyses
Analyzes protocol objectives and endpoints, then generates a ranked list of suitable statistical methods with references to ICH E9 and FDA guidance.
Draft Rationale Text
Creates clear justification language for each recommended analysis, ready to paste into protocol documents or review forms.
Generate Review Reports
Compiles a concise summary report with extracted design details, recommended analyses, and rationale, formatted for IRB or team review.
AI Agent FAQ
The agent reviews your protocol’s objectives, endpoints, and design, referencing standards like ICH E9 and FDA guidance. It suggests appropriate analyses and provides a ranked list with supporting rationale. Human review is still recommended before finalizing any analysis plan.
Yes, the agent can access protocols stored in SharePoint, Google Drive, or Box. You can upload documents directly or connect via secure API for batch processing.
All uploads are encrypted in transit using TLS 1.3 and deleted immediately after processing. No data is stored or shared. Security audits are performed quarterly to maintain compliance.
The agent is trained on a broad range of clinical trial designs, including crossover and adaptive protocols. For highly specialized or first-in-human studies, you can provide additional context to improve recommendations.
Most biostatisticians reduce protocol review time from nearly 2 hours per week to just 15 minutes, freeing up over $2,000 in annual labor costs.
Related tasks
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