Whether you need to provide documents for mandatory public posting, as part of a voluntary data sharing policy, or in conjunction with a planned publication, Kateric provides redaction resources in support of all data anonymization and transparency initiatives.
Our specialists have redacted hundreds of documents, following both industry standard guidelines (TransCelerate, EMA) and client-specific guidelines, often accommodating quick turnaround times. Whether you have 1 document or 100 documents that require redaction, Kateric’s dedicated and scalable redaction resources are available to handle any volume.
Document Redaction Services
We redact documents across both internal and external transparency obligations, including:
FDAAA: Final Rule
EMA: Policy 0070
Internal company policies
Third Party requests for information
Industry requirements
Publication (ICMJE) requests
Kateric's 2-Step Approach
Kateric uses a methodical, two-step approach to document redaction:
Step 1:
Our experienced redaction specialists perform a thorough review of each document, with use of both automatic and manual redaction tools and processes, ensuring patient and company confidential information are appropriately identified.
Step 2:
Every document then undergoes a rigorous quality review to ensure not only the protection of all relevant information but also the consistent application of all applicable standards and regulations.
Document Redaction Frequently Asked Questions
Do you have an EMA Policy 0070 submission process in place?
Yes, Kateric has a Policy 0070 submission process in place.
Do you complete the justification table as part of the Policy 0070 or just identify text for redaction?
Kateric completes the justification table in addition to identifying the text for redaction for Policy 0070 submissions.
Can you help prepare an anonymization report for a Policy 0070 submission?
Yes, Kateric can help with Policy 0070 anonymization reports.