DocQC™

Medical Writers automation
tool for QC checks

GI-DocQC-page-image
DocQC™​
DocQC™​

Medical Writers automation
tool for QC checks

Medical Writers automation
tool for QC checks

DocQC™ Product Videos

DocQC™ -Medical Writers automation
tool for QC checks

DocQC™ is a tool that automates QC checks, which historically required multiple, time-consuming cycles of manual review. The application is programmable for various complexities, supported by AI and ML algorithms, developed by your document SMEs. It increases the efficiency and effectiveness of your QC process with each use.

DocQC™ enables your medical writers to maintain their focus on the science, analysis, and presentation of results.

Medical Writers Automation Tool

Medical Writing Automation Tool for QC Checks

DocQC™ is a tool that automates QC checks, which historically required multiple, time-consuming cycles of manual review. The application is programmable for various complexities, supported by AI and ML algorithms, developed by your document SMEs. It increases the efficiency and effectiveness of your QC process with each use.

DocQC™ enables your medical writers to maintain their focus on the science, analysis, and presentation of results.

Essential Quality Checks for Clinical Documents

Lists in-text literature cross-references and checks conformance to AMA and Harvard styles. List in text literature cross references and checks for corresponding full citations in the list of references and vice-versa.

Checks in-text literature cross-references (titles and content) to ensure relevance and consistency with the source (titles and content) found in the appendices.

Lists in-text abbreviations and checks for corresponding entries in the list of abbreviations and vice-versa. Checks whether abbreviations from the list of abbreviations are correctly introduced at the first instance of their full-forms

Checks the post-text TFLs content (titles and column headers) to ensure they are relevant to the content of the section where they are referenced. (Note that this check excludes post-text TFLs referenced in the in-text tables).

Checks the CSR data/text against the referred source tables (in-text tables/post-text tables) to ensure relevance and consistency.

Checks data of Intext Tables based on the criteria mentioned in the Title of Tables against its corresponding Post-Text TFLs (source) and vice versa.

Lists post-text TFLs (aka “statements of fact”) and checks for corresponding entries in the appropriate appendices.

Checks content of in-text tables against corresponding post-text TFLs and vice-versa.

Shows content in CSR synopsis, relevant sections of CSR body, and appendices, using certain keywords.

Checks methods section of CSR against the corresponding section of the template or the Protocol/SAP.

Checks in-text patient (or subject) numbers in the CSR to ensure that there are corresponding entries in the patient narratives section.

Checks CSR against its standard template to confirm all required sections are present with appropriate section title.

Essential Quality Checks for Clinical Documents

Smart In-Text and Post-Text checks

Synopsis
Checks

Template
Checks

Abbreviation
Checks

Reference
Checks

Citation
Checks

Key Features

DocQC™ features support your efforts with

  • Removes time-consuming  multiple cycles of manual review.
  • Omits ambiguity by minimizing human error.
  • AI enabled algorithms
  • Reduction for time in CSR finalization from Last Visit – Last Treatment.
  • DocQC quality check’s while cross referencing other study artifacts including Protocol, SAP, and TLFs.
  • User-friendly interface for viewing and managing your QC check repository across several levels (Global Study).
  • Repository contains standard “out of the box” checks.
  • QC Reports generated to detail failed checks, instances and locations for the QC reviewer.
  • Performance Metrics Reports to track quality of your documents and your processes across QC phases.
  • On screen editing and commenting with downloading option in Track Changes mode along with Comments in Word File.
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Key Features

DocQC™ features support your efforts with

  • Removes time-consuming  multiple cycles of manual review
  • Omits ambiguity by minimizing human error
  • Reduction for time in CSR finalization from Last Visit – Last Treatment 
  • DocQC quality check’s while cross referencing other study artifacts including Protocol, SAP, and TLFs
  • User-friendly interface for viewing and managing your QC check repository across several levels (Global Study)
  • Repository contains standard “out of the box” checks 
  • Real-time and batch/scheduled execution options
  • Automatic execution of checks on new versions/updates of documents
  • QC Reports generated to detail failed checks, instances and locations for the QC reviewer
  • Performance Metrics Reports to track quality of your documents and your processes across QC phases
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Functionality of Our Quality Checks Automation tool

Looking to enhance your organization’s impact?

See how DocQC™ can help:

Ability to execute complex QC checks

Reviewing of items referencing source information in other sections of the document and/or other documents altogether

Able to compare QC documents to source

Tables/Figures/Listings (TFLs)

Datasets (e.g., SDTM, ADaM)

Patient Safety Narratives

High-Level Summary documents

Clinical Study Reports (CSRs)

Risk Management Plans (RMPs)

Publications and posters

Flexibility to accommodate documents of different format types

Formats include PDF, Word, and more.

Custom checks can be added

Add customized check to make your QC process more powerful and tailored to meet the specific needs of your organization’s standards/templates:

  • Taxonomies
  • Configurable QC checks engine
  • Ability to add new/custom QC checks

Configurable Rule Engine

Rules can be configured as per the requirement raised by the user

Medical Writers Automation Tool