QC, Review and Redaction

What We Do

We provide independent QC review for clinical and regulatory documents produced both by Niche and by other organisations. Independent review, carried out by someone who has not been involved in producing the document, consistently catches errors and inconsistencies that the original author has become too familiar with the content to notice. 

Redaction is a distinct service that has become increasingly important as clinical study data is routinely made available under transparency initiatives. We redact clinical documents to protect personal data and commercially sensitive information while preserving the scientific integrity and utility of the content.

What We Do

QC review follows a structured checklist-based process, but it is not a mechanical exercise. Our reviewers read documents critically, checking factual accuracy against source data, internal consistency across sections, compliance with relevant guidelines, and adherence to style and formatting requirements. 

Redaction work is carried out with a clear redaction strategy agreed in advance, specifying which categories of information will be removed or obscured and on what basis. We maintain a redaction log throughout and provide a clear audit trail of all changes made.

Scope Of Service 

• Scientific and factual accuracy checks against source data 
• Internal consistency review across document sections 
• Reference and citation verification 
• Guideline compliance checks (ICH, FDA, EMA) 
• Formatting and style guide adherence 
• Table, figure and listing verification 
• Abbreviation and terminology consistency 
• Clinical study report QC review 
• Regulatory submission document review 
• Clinical document redaction for transparency submissions 
• Personal data identification and removal 
• Commercially sensitive information redaction