DocQC

DocQC™ is a medical writers automation tool developed by GENINVO that automates quality control checks for clinical documents — checks that have historically required multiple, time-consuming cycles of manual review. Powered by AI and ML algorithms and programmable for various levels of complexity by document subject matter experts, DocQC™ increases the efficiency and effectiveness of the QC process with each use, enabling medical writers to maintain their focus on the science, analysis, and presentation of results.

DocQC™ is designed for medical writing teams working on clinical study reports (CSRs) and related regulatory deliverables. By automating cross-referencing, consistency checks, and data verification across study artifacts including Protocols, Statistical Analysis Plans (SAPs), and Tables, Figures, and Listings (TFLs), the tool significantly reduces the time required for CSR finalization from Last Patient – Last Visit.

Essential Quality Checks for Clinical Documents

• Reference Match Format List: Lists in-text literature cross-references and checks conformance to AMA and Harvard citation styles, verifying that corresponding full citations exist in the reference list and vice-versa.
• Reference Match Content: Checks in-text literature cross-references — including titles and content — against source material found in the appendices to ensure relevance and consistency.
• Abbreviation Match List: Lists in-text abbreviations and checks for corresponding entries in the list of abbreviations and vice-versa, and verifies that abbreviations are correctly introduced at the first instance of their full forms.
• Post-text TFL Content: Checks post-text TFL titles and column headers to ensure they are relevant to the content of the section where they are referenced (excluding post-text TFLs referenced in in-text tables).
• In-text Match Post-text: Checks CSR data and text against referred source tables — both in-text and post-text — to ensure relevance and consistency.
• Threshold Table: Checks data in in-text tables based on criteria mentioned in table titles against corresponding post-text TFLs and vice-versa.
• SOF Citation: Lists post-text TFLs (statements of fact) and checks for corresponding entries in the appropriate appendices.
• SOF Match Data Source including Reverse Check: Checks the content of in-text tables against corresponding post-text TFLs and vice-versa.
• Multiple Documents Keyword Check: Displays content across the CSR synopsis, relevant sections of the CSR body, and appendices using specified keywords.
• CSR Match Protocol SAP: Checks the methods section of the CSR against the corresponding section of the template or the Protocol/SAP.
• CSR Match Narrative: Checks in-text patient or subject numbers in the CSR to ensure corresponding entries exist in the patient narratives section.
• CSR Match Template: Checks the CSR against its standard template to confirm all required sections are present with appropriate section titles.

Key Features and Capabilities

• Removes time-consuming multiple cycles of manual review and minimises human error and ambiguity.
• AI-enabled algorithms that improve with each use.
• Reduces time in CSR finalization from Last Patient – Last Visit.
• Cross-references other study artifacts including Protocol, SAP, and TFLs during QC checks.
• User-friendly interface for viewing and managing the QC check repository across multiple levels, including global and study levels.
• Repository contains standard out-of-the-box checks ready for immediate use.
• QC reports generated to detail failed checks, instances, and locations for the QC reviewer.
• Performance metrics reports to track document quality and process quality across QC phases.
• On-screen editing and commenting with a downloading option in Track Changes mode, along with comments exported in Word file format.

Functional Capabilities

• Ability to execute complex QC checks across large and intricate clinical documents.
• Ability to compare QC documents directly to source documents.
• Flexibility to accommodate documents of different format types.
• Custom checks can be added to meet organisation-specific requirements.
• Configurable rule engine allowing programmability for various document complexities.

DocQC™ is built to support medical writing organisations seeking to enhance quality, reduce review cycle times, and standardise QC processes across studies. The tool's configurable and extensible architecture makes it suitable for teams operating at both global and study levels within regulated life sciences environments.