Designing Packaging Labels for Blinded Clinical Studies

 Blinded studies are the cornerstone of clinical trial integrity, eliminating bias and ensuring objective evaluation of investigational products. However, behind the scientific rigor lies a critical creative component—the package labels for clinical trials. For Regulatory artwork teams, designing for blinded trials is a balancing act between compliance, confidentiality, and clarity.

At Freyr Solutions, we specialize in regulatory-compliant, audit-ready artwork for global clinical trials. In this blog, we explore how clinical trial packaging artwork must be tailored to meet the unique demands of blinded studies.

Why Artwork Matters in Blinded Studies

Designing packaging labels for blinded studies (typically in clinical trials) involves unique processes to maintain blinding and ensure compliance with Regulatory and trial-specific requirements.

Unlike commercial products, the artwork for blinded studies must conceal product identity, yet provide clear, regulatory-approved information to end-users such as investigators, pharmacists, and patients. Any discrepancy—be it in color, shape, typography, or labeling content—can unintentionally unblind the study.

Artwork in blinded studies must therefore have key objectives:

• Ensure Blind Integrity: The label must not disclose any information that could reveal the treatment identity. Visual consistency must be maintained across all study arms.
• Usability: Ensure safe and correct use (e.g., proper application by site staff). Prevent product differentiation through design elements..
• Handle variable data: Key variable data elements—such as randomization codes, expiry dates, kit numbers, patient IDs, and visit-specific information must be available.
• Regulatory Compliance: Be compliant with global/regional clinical trial regulations
• Traceability: Ensure clear linkage to trial and patient without revealing product type. It should be version-controlled and support auditability.

Process of creating Package Labels for Blinded Clinical Studies

The Blinded Labeling Design Process begins with gathering requirements through protocol review and stakeholder input, ensuring alignment with country-specific regulations. Neutral label text is developed using terms like “Study Medication” and includes critical information such as trial numbers, expiry dates, and cautionary statements, while avoiding identifiers that may reveal treatment. Randomization and kit mapping are securely handled, with labels designed to maintain blinding, often using barcodes. Design mockups are created considering container size, multilingual needs, and overlay requirements. Regulatory and translation reviews ensure global compliance. QA and Clinical teams verify protocol alignment, while label proofs undergo electronic checks and formal approvals. Label application strategy—whether primary, secondary, or Overlabeling—accounts for environmental constraints. Controlled printing, often just-in-time, ensures serialized traceability and final packaging is completed under QA oversight to confirm label accuracy, adhesion, and blind integrity.

Key Artwork Considerations for Blinded Study Labels

Artwork Element	Design Requirement in Blinded Studies	Freyr’s Artwork Strategy
Color Scheme	Avoids color differentiation that could indicate treatment arms	Uniform color palettes across all arms; grayscale or neutral tones preferred
Fonts and Typography	Uniform font style and size across all variants to avoid visible clues	Predefined typography guidelines are applied uniformly across label artworks
Label Layout & Hierarchy	Positioning of text & graphics as per technical guidelines	Template-based design layouts to ensure uniformity
Placebo vs Active Labeling	Must not have any visual differences	Use identical label templates; only variable fields differ via encoded data.
Randomization/Tracking Codes	Must be present but not interpretable by the end-user	Ability to generate any barcodes.
Language Management	Multilingual content should not introduce layout biases	Language blocks are designed with a symmetrical layout.
Dynamic Data Fields	Data like batch, expiry, and component ID change per pack	Placeholder fields or as agreed upon by the packaging for placement
Label Material and Format	Must allow blinding and unblinding as per study needs	Use of booklet labels, peel-off Labels, or Overlabels as required
Version Control & Approval	Labels are updated often due to protocol amendments	Centralized artwork management with version control of labels and approval management

Regulatory Body References for Clinical Trial Labeling

Region	Regulatory Body	Guideline Reference
EU	EMA	Annex VI of Regulation (EU) No 536/2014
US	FDA	21 CFR Part 312.6
UK	MHRA	Good Clinical Practice Guide
Canada	Health Canada	Guidance Document for Clinical Trial Sponsors

Common Errors in Blinded Study Artwork (and How to Avoid Them)

✗ Use of different label dimensions for active/placebo
✓ Standardize size and shape across all arms

✗ Language placement varies between countries
✓ Use mirrored language blocks with consistent formatting

✗ Visible batch/product IDs on product artwork
✓ Use coded data and barcodes to conceal visible identifiers

Why Partner with Freyr for Blinded Study Artwork?

• Blinded label design expertise for global trials
• Regulatory intelligence availability across the US, EU, UK, Canada, and APAC regions
• Usage of Artwork management Tool if required. The tool can be customized to meet clinical trial requirements.
• Version-controlled, compliant, audit-ready files
• Multilingual capability and technical proofreading of labels for any given country or region