Clinical & Medical Documentation
Clinical documentation that stays connected to the evidence it comes from.
Clinical development generates large, interdependent document sets: protocols and their amendments, statistical outputs, study reports and the summaries built from them. Each document draws on the others, and consistency across them matters as much as the content of any one.
The challenge
Where the effort goes today
Study reports and summaries are assembled from hundreds of tables, figures and listings, protocols, and earlier documents.
Amendments and new data ripple across related documents, and keeping them consistent is slow, manual work.
Medical writers and clinicians spend much of their time locating and reconciling information rather than interpreting it.
What Liorta provides
Lorgani™, applied to Clinical & Medical Documentation.
Outcomes, not a black box: organized evidence, structured drafts, traceable content and governed review - with people making every decision that matters.
Evidence brought together
Clinical sources organized around the document being prepared.
Structured clinical drafts
Content prepared in the expected structure of the document type, for expert refinement.
Cross-document consistency
Related documents kept aligned as protocols and data change.
Expert review
Clinical and medical experts review, refine and approve.
Use cases
Where Lorgani applies in Clinical & Medical Documentation
A named application is shown where one relates to the use case today. Other use cases are areas where the platform can be applied - talk to us about your priorities.
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Clinical Study Report (CSR)
The integrated report of a clinical study’s methods and results.
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CSR Synopsis
A concise summary of a study report for submissions and disclosure.
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Investigator’s Brochure
The compilation of clinical and nonclinical data on an investigational product.
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Informed Consent / Patient Information
Participant-facing documents that explain a study clearly and accurately.
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Clinical Development Plan
The strategy and sequence of studies for a development programme.
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CTD Module 2 Clinical Overview
The critical assessment of clinical data within the Common Technical Document.
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CTD Module 2 Clinical Summary
The detailed factual summary of clinical information within the Common Technical Document.
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Data Monitoring Committee Package
Documentation prepared for independent data monitoring committee review.
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Clinical Trial Disclosure Summary
Results and lay summaries for public trial registries and disclosure obligations.
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Inputs and outcomes
Information involved
- Protocols and amendments
- Statistical analysis plans
- Tables, figures and listings
- Investigator’s Brochure
- Earlier study reports and summaries
- Published clinical evidence
Outcomes enabled
- Structured clinical documents ready for expert review
- Consistency across related documents
- Less time spent locating and reconciling information
- Traceability from statements to source outputs
Where people stay involved
Medical writers, clinicians and statisticians interpret results, shape the narrative and approve every document.
Related application
CliDossi - Intelligent Clinical Dossiers
Apply Lorgani to complex clinical and evidence-intensive documentation and reporting.