Regulatory Compliance
Generate protocol and CSR documents as per ICH guidelines with the help of Machine Learning.
Faster Approvals
Reduce the number of reviews required as automation generates formatted documents, reducing errors and edits by 60 - 70%.
Reduce Authoring Time
With the auto-generation of 60-70% of study and submission documents within minutes, medical writers experience tremendous time savings from authoring reports manually.
Cost Reduction
Scale down costs and improve productivity by automating study and submission document generation.
Intelligent Document Automation Enabling Faster Study Design And Regulatory Submission.
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Compliance
DrivenGenerate Protocol & CSR documents as per ICH guidelines
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Dynamic
TemplatesMaster CSR & Protocol
templates -
Report
CustomisationCustomise study-specific protocols and CSRs
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Intelligent
MappingAuto and manual mapping
using AI
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Collaborative
AuthoringCollaborate online using
AWS workspaces -
Submission-Ready
DocumentGenerate finalised Protocol and CSR documents