The biopharmaceutical industry is undergoing a significant transformation, with GenAl reshaping every phase of the drug-to-market journey. Companies are increasingly investing in Al-powered tools to modernize workflows, gaining a competitive edge through increased speed, quality and reduced cost. Shorthills' Al-Powered Clinical Study Report generation methodology and tools provide a faster, smarter, and compliant approach by automating the repetitive, time-consuming tasks.
Complex clinical
trial data
Information and data in high volumes required for the CSR needs to be extracted from several, often disparate, source documents and databases.
Significant manual effort and long review cycles
The final draft can consist of several hundred pages and medical writers need time to follow best practices set forth in the ICH E3 guidelines when conducting their quality assurance (QA) reviews.
Risk of delayed submissions or application rejection
Risk of inconsistencies and errors during iteration in sections like the adverse event narratives and statistical reporting can impact regulatory approval of the drug application.
Shorthills AI Approach to Leverage AI
Shorthills Al has developed an innovative and agentic-powered CSR drafting tool that leverages our extensive expertise in data and Al. This solution is perfectly suited to handle large and complex datasets, helping medical writers draft CSRs 30-50% faster while ensuring compliance.
Populate the most onerous subsections of the CSR
Auto-fetch clinical and statistical data from source documents and databases to reduce time required to extract the pertinent information.
Create CSRs with Al-powered intelligent drafting
Leverage Al to generate CSR sections in format that aligns with ICH E3 guideline.
Automate QA and compliance checks
Use Al agents to scan sections within CSR to automatically detect inconsistencies, formatting issues, and regulatory non-compliance prior to human QA and validation.
Selection of Gen Al Tool
Step 1
GEMINI 2.5 PRO
Generate CSR sections and structured summaries
GOOGLE ADK
Build and orchestrate
multi-step automation workflows
A2A PROTOCOL
Enable agent-to-agent
coordination and reliable execution
Automating CSR Sections with Al
Step 2
AUTOMATING
CSR SECTIONS WITH AL
Data extraction and preprocessing
Extract relevant objectives, design, results, safety
GENERATING DRAFTS WITH GEN AI
Auto-generate CSR sections (Synopsis, Objectives, Design, Efficacy, Safety)
Maintain consistent style and ICH E3 structure
REVIEWING & REFINING THE REPORT
Merge sections into cohesive report
Automated consistency and compliance checks
Selection of Gen Al Tool
Step 2
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Follow ICH E3 guidelines
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Maintain data privacy and integrity
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Version control and documentation
Selection of Gen Al Tool
Step 2
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Convert the document to regulatory formats (CTD)
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Submit via regulatory platforms (FDA, EMA, PMDA portals)
Our Solution in Play
Accelerated Timelines
40% reduction in the time required to produce first-draft CSRs.
Improved Accuracy
Over 98% accuracy rate.
Reduced Risk
Minimizes the risk of submission delays and rejections.
Enhanced Collaboration
Streamline the QA process.
The Business’ Impact
A Leap in Efficiency and Accuracy
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