Designing Packaging Labels For Blinded Clinical Studies

Blinded clinical studies are often called the gold standard of medical research—and for good reason. They help eliminate bias and ensure that the evaluation of an investigational product is truly objective.

Most people think of blinded trials in terms of study design, patient safety, or data management. But there’s another piece of the puzzle that doesn’t always get the spotlight: the clinical trial packaging label.

It might look simple from the outside, but for Regulatory Artwork Teams, designing labels for blinded studies is a high-stakes balancing act. It’s not just about putting text on paper—it’s about ensuring compliance, protecting confidentiality, enabling traceability, and above all, preserving the blind.

At Maven, this is what we do every day. We help global sponsors create packaging artwork that is not only compliant and audit-ready but also carefully crafted to protect the integrity of their studies.

Why Labels Matter More Than You Think

Unlike consumer packaging that thrives on eye-catching designs, clinical trial labels are built on neutrality and precision. They must conceal the product’s identity, while still providing clear and accurate information to the people who rely on them—investigators, pharmacists, and patients.

The stakes are high. A small oversight—say, a different shade of ink or a font inconsistency—could unintentionally give away which treatment a patient is receiving. And that single slip could compromise years of research.

That’s why every blinded study label is designed with a few critical goals in mind:

• Keep the blind intact – every arm of the study must look identical.
• Ensure usability – labels must guide clinical staff to handle products correctly.
• Manage variable data – things like expiry dates, kit numbers, and patient IDs have to be accurate and secure.
• Stay compliant – every label must meet strict regional and global regulatory rules.
• Maintain traceability – each pack must link back to the trial and the patient, but without revealing treatment details.

The Label Design Journey

Creating blinded study labels is not a one-step job—it’s a collaborative process that brings together scientific, regulatory, and operational expertise. Here’s what it typically looks like:

1. Gathering Requirements – reviewing the study protocol, engaging stakeholders, and mapping out regulatory needs.
2. Neutral Text Creation – avoiding brand names; using generic terms like “Study Medication” while including essential details (protocol number, expiry, caution statements).
3. Secure Coding – adding randomization codes and barcodes that aid traceability without revealing product identity.
4. Designing Mockups – considering packaging sizes, language requirements, and label formats (booklet, peel-off, or overlays).
5. Regulatory & Translation Review – ensuring labels meet EMA, FDA, MHRA, Health Canada, and regional standards.
6. Cross-Functional Checks – QA and Clinical teams verify everything against the study protocol.
7. Proofing & Approval – electronic proofing, version control, and formal sign-offs.
8. Application Strategy – choosing how labels are applied (primary, secondary, or overlays) to fit the product type and environment.
9. Controlled Printing & Packaging – just-in-time printing, serialization, and QA oversight to confirm blind integrity is maintained.

Key Considerations in Blinded Label Design

Common Pitfalls (and How to Avoid Them)

• Different label sizes for placebo vs active → Always standardize across arms.
• Inconsistent language placement across countries → Use mirrored, uniform layouts.
• Visible batch IDs on the label → Encode identifiers within barcodes instead.

These may seem like small details, but in blinded studies, details are everything.

Why Sponsors Partner with Maven

• Experience designing blinded labels for global Phase I–IV studies
• Regulatory know-how across US, EU, UK, Canada, and APAC
•  Multilingual capabilities with technical proofreading built-in
•  Customizable Artwork Management Tools to track versions and approvals
•  Audit-ready, serialized labels delivered within tight study timelines
•  End-to-end support—from first draft to final print under QA oversight

Final Thoughts

In blinded clinical trials, labels are far more than “stickers on a bottle.” They are regulatory safeguards—informing without revealing, tracking without bias, and protecting the blind without compromise.

As trials grow more complex and global, sponsors need partners who understand the delicate balance between creativity and compliance.

At Maven, we bring together regulatory intelligence, design expertise, and robust artwork systems to deliver packaging labels that keep your studies blind, compliant, and audit-ready.