In many industries, Design for Quality (DfQ) has long been a guiding framework. It teaches us to build quality into the process rather than inspecting for it later. That philosophy has helped reduce errors, improve compliance, and strengthen trust across every stage of drug development.
At TrialAssure, we believe transparency deserves the same strategic approach. That’s why we have developed Design for Transparency™, a forward-thinking model that ensures clinical trial disclosure and data sharing are supported from the beginning and not treated as last-minute fixes.
What Is Design for Transparency?
Design for Transparency is a structured, organization-wide framework for embedding transparency practices directly into the planning, documentation, and submission processes of clinical trials. Like DfQ, this approach promotes proactive alignment. It recognizes that transparency must be built into how teams think, communicate, and document their work.
This means that every dataset, every document, and every workflow should be created with the assumption that it may one day become publicly available. That includes content submitted through ClinicalTrials.gov, CTIS, or other disclosure platforms, as well as plain language summaries, redacted regulatory documents, and shared datasets.
“When we embed Design for Transparency into the earliest stages of clinical trial planning and documentation, we prevent delays and create stronger outcomes for every stakeholder,” said Zach Weingarden, MS, Director of AI Technology & Applications at TrialAssure.
The goal of Design for Transparency is to generate better, more intentional work that is built to meet regulatory requirements, withstand scrutiny, and foster greater public trust.
Why This Philosophy Matters
It is no surprise that regulatory timelines for transparency have grown tighter. Global requirements are more complex, and they are about to become even more so. Additionally, public expectations around data access have never been higher. Treating transparency as an afterthought increases the risk of delays, rework, or missed obligations.
When teams are not aligned early on, they face common issues, including but not limited to:
- Inconsistent definitions of commercially confidential information (CCI)
- Redundant documentation or conflicting versions of content
- Bottlenecks during redaction, review, and disclosure
- Unnecessary changes to core documents late in the process
- Reduced readiness for inspections or audits
Prasad Koppolu, COO at TrialAssure, shares this: “Regulators, patients, and partners all expect clarity and accountability. Design for Transparency gives Sponsors a repeatable way to meet those expectations with fewer surprises and better coordination across teams.”
By incorporating Design for Transparency principles from the start, Sponsors and CROs can reduce these issues and build consistency into every step of the clinical trial lifecycle.
What It Looks Like in Practice
Design for Transparency involves several practical shifts across an organization:
- Content Development: Medical writers and regulatory authors document with transparency in mind, writing leaner, clearer content that avoids unnecessary detail and is easier to review and redact.
- Cross-Functional Alignment: Teams across clinical, regulatory, legal, and disclosure functions are trained to identify and flag sensitive content consistently.
- Structured Systems: Tools like TrialAssure REGISTRY and ANONYMIZE support workflows that promote compliance by design.
- Governance and Oversight: Organizations track the classification of sensitive information over time, ensuring decisions stay up to date and defensible.
- Audit-Ready Processes: Quality checks, version control, and user review steps are embedded across the workflow.
Just as Design for Quality resulted in fewer defects and stronger submissions, Design for Transparency leads to better efficiency, improved stakeholder communication, and greater regulatory success.
The Risk of Staying Reactive
When transparency is treated as an endpoint rather than a built-in goal, organizations often pay the price in delays or potential fines. Rewriting sections of protocols, resolving conflicting interpretations of CCI, or navigating last-minute redaction issues can burn valuable time and increase risk.
Transparency should not be a surprise to anyone involved. It should be a shared understanding. That’s the value of designing for it.
Let’s say that a mid-sized biotech preparing a CTIS submission finalizes its protocol and Investigator’s Brochure without considering future public disclosure. Once the transparency team begins redacting, they will likely discover that the documents contain detailed proprietary content (e.g., manufacturing processes, exploratory endpoints, etc.) that should have been flagged as commercially confidential information (CCI) earlier. With submission deadlines approaching, the team may be forced into a last-minute scramble, rushing legal and scientific reviews, resolving version mismatches, and risking non-compliance. This situation could have been avoided with a Design for Transparency approach that aligns teams from the start.
TrialAssure’s Commitment
TrialAssure has long championed this model through our technology and services. Our AI-powered platforms, including REGISTRY, LINK AI, and ANONYMIZE, are designed to support structured workflows, eliminate ambiguity, and help Sponsors stay aligned with global transparency expectations.
Design for Transparency is a better way to build clinical research infrastructure that scales, adapts, and delivers. If your organization is ready to shift from reactive transparency practices to a more strategic and aligned approach, we’re here to help.
