Clinical Document Writer

Cut Documentation Time by 40% with AI that Works with You: Our solution uses Amazon Bedrock and Amazon SageMaker AI to create compliant documentation. It integrates fragmented data sources through agentic intelligence to automatically generate comprehensive regulatory documents (from protocols to patient safety narratives) with built-in quality checks that identify inconsistencies in real-time. By incorporating real-world evidence and automating routine document elements, this approach significantly reduces document creation while cutting documentation costs in half, allowing clinical teams to focus on strategic priorities rather than administrative tasks.

Driving Business Value: Ensuring growth, efficiency, and success through strategic alignment

• Document Generation: Creation of protocols, clinical study reports, safety narratives, and other critical submission documents
• Quality Control: Automation Built-in systems to identify errors, inconsistencies, and compliance issues before they impact submissions
• Evidence Integration: Seamless incorporation of relevant data and insights into safety and health economics documentation
• Compliance Management: Continuous updates to reflect evolving submission guidelines across global regulatory authorities

Taking Action Delivering work that ensures successful execution and maximum impact

• Discovery Workshop: Assessment of documentation challenges and opportunities for automation and improvement
• Proof of Value: Targeted implementation demonstrating measurable improvements in document creation speed and quality
• Implementation Roadmap: Detailed plan for full solution deployment with integration requirements and change management considerations