DocQC

DocQC™ is a sophisticated application designed to automate quality control (QC) checks in medical writing, traditionally a process requiring extensive manual review. By programming the application to handle various complexities, it significantly enhances the efficiency and effectiveness of the QC process, allowing medical writers to concentrate on scientific analysis and presentation.

DocQC™ performs essential quality checks on clinical documents, such as verifying in-text literature cross-references and ensuring conformity with AMA and Harvard styles. It checks for corresponding full citations in reference lists and ensures in-text abbreviations are correctly introduced and listed. The application also verifies the relevance and consistency of post-text tables, figures, and listings (TFLs) with the content they reference.

Additional checks include ensuring the consistency of clinical study report (CSR) data with source tables, verifying patient numbers in narratives, and confirming that all required sections are present in CSRs according to standard templates. The tool also supports smart in-text and post-text checks, synopsis checks, template checks, abbreviation checks, reference checks, and citation checks.

Key Features

• Eliminates time-consuming manual review cycles.
• Reduces ambiguity and human error.
• Accelerates CSR finalization from last patient visit to last treatment.
• Cross-references study artifacts like Protocol, SAP, and TLFs.
• Offers a user-friendly interface for managing QC checks globally.
• Includes standard out-of-the-box checks and generates detailed QC reports.
• Provides performance metrics reports to track document quality across QC phases.
• Supports on-screen editing and commenting with track changes in Word files.

DocQC™ is capable of executing complex QC checks by reviewing items that reference source information in other document sections or entirely different documents. It can compare QC documents to sources such as TFLs, datasets, patient safety narratives, and more. The tool accommodates various document formats, including PDF and Word, and allows for the addition of custom checks to tailor the QC process to specific organizational standards.

With a configurable rule engine, users can adjust rules according to their requirements, making DocQC™ a flexible and powerful solution for automating quality checks in medical writing.