Medical Writing QC Automation Solutions

for Pharma Biotech

Accelerate Accuracy and Compliance

With the increase in regulatory expectations and submission timelines getting shorter, quality control in medical writing has become more complex and resource-intensive. Traditional manual QC processes are no longer sufficient to handle growing document volumes, evolving global regulations, and increasing scrutiny from health authorities.

At DDi, we understand that errors in medical documents can lead to regulatory questions, submission delays, rework, and reputational risk. Even minor inconsistencies in tables, figures, or references can trigger agency queries. Our Medical Writing QC Automation solution delivers the speed, accuracy, and regulatory confidence you need to stay ahead.

The Challenge: Limitations of Manual QC

While human review remains essential, manual QC alone presents several challenges.

• Time-Consuming: Reviewing lengthy clinical documents line by line slows down submission timelines and increases pressure on medical writers.
• Human Error: Fatigue, repetitive checks, and tight deadlines can lead to missed inconsistencies or overlooked formatting issues.
• Lack of Standardization: Different reviewers may apply QC rules inconsistently, leading to variable quality across documents and projects.
• Scalability Issues: As organizations expand globally, maintaining consistent QC manually becomes increasingly complex.

Our Solution: Intelligent Automation and AI

Automation introduces rule-based checks and AI capabilities that systematically validate documents against predefined standards. Our platform allows medical writers and QC reviewers to focus on higher-value scientific and regulatory assessments rather than mechanical tasks by automating repetitive checks.

Key capabilities include:

• Template Compliance: Ensure documents follow organizational standards and regulatory expectations every time.
• Rapid Scanning: Instantly scan documents for hundreds of parameters that would take hours to review manually.
• Comprehensive Validation: Automate checks for data consistency, formatting, style guide adherence, reference validation, and table/figure verification.