Clinical Study Report
(CSR) Generation

AI-LED AUTOMATION

For driving improved outcomes

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.

Key Challenges

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 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.

Step 1

Selection of Gen Al Tool

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

Step 2

Automating CSR Sections with Al

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

Step 3