Sold by: Hexaware Technologies
MedWriter.ai is Hexaware’s enterprise AI solution for accelerating the creation of Clinical Study Reports (CSRs) and other clinical and regulatory documents in regulated environments. By securely ingesting approved study inputs—such as protocols, SAPs, Investigator’s Brochures, and TLFs—it generates structured, high-quality drafts with greater speed, consistency, and control. Built on scalable AWS infrastructure, MedWriter.ai supports secure collaboration, streamlined review and approval workflows, and standardized document development across medical writing, clinical, biostatistics, and regulatory teams. The result is reduced manual effort, faster review cycles, improved standardization, and stronger submission readiness.
Overview
MedWriter.ai is Hexaware’s enterprise-grade, AI-powered solution for modernizing clinical and regulatory document authoring across life sciences organizations. In regulated environments, medical writing teams must produce high-quality, submission-ready documents while coordinating across multiple stakeholders, managing complex source materials, and meeting demanding regulatory timelines. Traditional document development is often manual, fragmented, and time-intensive—resulting in avoidable delays, inconsistent outputs, and high review burden.
MedWriter.ai addresses these challenges by combining AI-driven draft generation, secure document ingestion, and workflow-enabled collaboration in a single platform designed for clinical and regulatory use cases.
The solution securely ingests approved study inputs such as the Clinical Study Protocol, Statistical Analysis Plan (SAP), Investigator’s Brochure (IB), Tables, Listings and Figures (TLFs), and related source content to generate structured, high-quality first drafts for Clinical Study Reports (CSRs) and a broad range of other clinical and regulatory documents. This helps teams reduce repetitive manual drafting, improve consistency across sections and documents, and accelerate document development timelines.
Built on secure, scalable AWS infrastructure, MedWriter.ai is designed to support the needs of enterprise life sciences organizations operating in regulated settings. It enables controlled, cross-functional collaboration among medical writing, clinical, biostatistics, and regulatory teams through integrated review and approval workflows—helping reduce handoff delays, minimize rework, and improve operational alignment.
By shifting effort away from repetitive drafting and document assembly, MedWriter.ai allows teams to focus more on scientific accuracy, clinical interpretation, and content quality. The outcome is a more efficient, standardized, and submission-ready document authoring process.
Key Features
- AI-powered generation of Clinical Study Reports (CSRs) and other clinical/regulatory documents
- Secure ingestion of approved source content, including Protocols, SAPs, IBs, TLFs, and related study materials
- Structured draft creation to improve consistency, completeness, and document quality
- Integrated collaboration, review, and approval workflows across cross-functional stakeholders
- Standardized document development to support repeatability across studies and submissions
- Secure, scalable AWS-based deployment for enterprise reliability and performance
Business Benefits
- Accelerates authoring timelines by reducing repetitive manual drafting effort
- Shortens review cycles through better-structured drafts and coordinated workflows
- Improves consistency and standardization across studies, teams, and submissions*
- Enhances cross-functional productivity by streamlining collaboration across medical writing, clinical, biostatistics, and regulatory teams
- Strengthens submission readiness with faster generation of high-quality draft documents • Supports operational efficiency at scale for pharmaceutical, biotechnology, and CRO organizations.
Highlights
- Purpose-built for regulated life sciences environments to accelerate Clinical Study Reports (CSRs) and other clinical/regulatory documents using approved study inputs.
- Combines AI-generated drafting with integrated collaboration, review, and approval workflows to reduce manual effort and shorten review cycles.
- Built on secure, scalable AWS infrastructure to improve standardization, cross-functional efficiency, and submission readiness.
Details
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