Balancing Global Standards and Local Autonomy

The CLARITY Model for Global Disclosure

Global clinical trial disclosure is increasingly complex, especially as sponsors work to keep pace with country-specific regulations while maintaining consistent corporate standards. Biopharmaceutical companies often rely on local affiliates or clinical research organizations (CROs) for submissions, but this decentralized approach can create compliance blind spots and inefficiencies. Rather than imposing a centralized “command and control” system, sponsors can adopt a flexible but structured model that sets global requirements and governance while enabling local expertise to drive submissions. The following seven-step plan outlines a practical framework for harmonizing processes, ensuring compliance, and optimizing resource use—ultimately striking the right balance between centralized oversight and local autonomy.

The CLARITY Model is at the heart of this approach, a seven-step blueprint for building a robust yet agile disclosure function. Each letter represents a key pillar:

1. Central governance & SOPs
2. Local empowerment
3. Accountability
4. Roadmap for improvement
5. Integrated technology
6. Training & culture
7. Year-round oversight

By following these principles, organizations can unify their global disclosure strategy while respecting local nuances. The CLARITY Model establishes a clear governance framework, empowers affiliates and CROs, outlines practical steps to enhance or implement technology, and ensures continuous training and auditing to maintain high-quality clinical trial disclosures worldwide.

1. Central governance & SOPs

Establish a global disclosure governance framework

Create a cross-functional governance body (such as a Disclosure Council or Center of Excellence) that sets minimum standards, policies, and KPIs for global disclosures. This body should:

• Include representatives from key regions and functional areas (regulatory, clinical operations, legal, etc.)
• Be responsible for interpreting global regulations (leveraging tools such as TrialScope Intelligence) and issuing clear guidance with standard operating procedures (SOPs), timelines, and templates)
• Oversee consistency in how affiliates/CROs conduct disclosures — without micromanaging local operations
• Conduct quarterly calls and offer newsletters or lunch-and-learns with affiliates/CROs to share updates/best practices and keep everyone aligned
• Proactively identify potential disclosure risks (e.g., upcoming regulatory changes, areas of noncompliance) and develop mitigation strategies

Define global SOPs and local work instructions

• A baseline global SOP for disclosure activities ensures uniform standards for key disclosure documents (e.g., protocol and results summaries, synopses, and lay summaries). Standard workflows for review and approval should be defined, even if execution is partly local. This fosters consistency. Affiliates/CROs should be allowed to develop local work instructions reflecting country-specific requirements or registry nuances.

Why it matters

A well-defined governance structure reduces confusion, accelerates decision-making, and promotes consistent, high-quality disclosures.

2. Local empowerment

Implement a “hub-and-spoke” operating model

Responsibilities of the hub (central coordination):

• Maintain the central knowledge repository, curated by the governance body, for disclosure requirements in every country where the organization conducts clinical trials)
• Develop standardized templates, training materials, and checklists for local affiliates
• Provide local affiliates and CROs with a single, pre-approved dataset covering the critical fields required by multiple registries to ensure consistency across disclosures
• Track global disclosure timelines and performance metrics (e.g., compliance rates, quality metrics)

Responsibilities of the spokes (local affiliates/CROs)

• Retain responsibility for day-to-day disclosure tasks in their respective jurisdictions
• Leverage the central resources (e.g., regulatory intelligence tools, SOPs, or guidelines) to ensure consistency
• Escalate issues or uncertainties to the central governance body for resolution

Why it matters

This structure allows regional flexibility while preserving global standards and a unified oversight approach.

3. Accountability

Define a clear RACI (responsible, accountable, consulted, informed) matrix

Responsibility allocation

• Assign “responsible” roles at the local affiliate/CRO level for each regulatory submission or major milestone (e.g., registration, results posting, updates)
• Ensure a designated “accountable” party within the corporate disclosure group who oversees compliance metrics globally

Consulted & informed

• The governance body and relevant subject matter experts (e.g., medical writers and biostatisticians) should be consulted.
• Senior management and quality assurance should remain informed of critical milestones, issues, or risk areas.

Why it matters

Clarity with roles eliminates duplication of effort, fosters accountability, and supports seamless collaboration with external partners

4. Roadmap for improvements

Step-by-step Approach for best results

Phase 1: Establish baseline & quick wins

• Roll out consistent SOPs, training, and a simplified global tracker
• Focus on high-volume or high-risk countries first
• Distribute approved standard disclosure datasets based on the World Health Organization (WHO) trial registration dataset and the ICHe3 results synopsis and include links to disclosed data on ClinicalTrials.gov or the Clinical Trials Information System (CTIS) if available

Phase 2: Strengthen oversight & analytics

• Enhance reporting capabilities (compliance dashboards, escalation triggers)
• Collect data on adherence to timelines and quality to identify gaps

Phase 3: Optimize & scale

• Integrate advanced automation where possible (e.g., structured data uploads and automated compliance alerts)
• Implement ongoing process improvements based on feedback and audit findings

Why it matters

By identifying quick wins and scaling gradually, organizations can maintain stakeholder buy-in, build internal capability, and course correct before full global adoption.

5. Integrated technology

Leverage an integrated technology platform

Centralized tracking & documentation

• Even if local teams complete the submissions, deploy a single global tracking platform (or extend your existing system such as TrialScope Disclose) for real-time updates and oversight
• Maintain a standardized data collection form within the disclosure platform to automate data entry and reporting for the main registries
• Store documents, including submission confirmations, approval notices, or PDF copies of the registry records, in a unified, auditable repository accessible to all stakeholders

Role-based access & permissions

• Assign different permission levels so local teams and CROs can manage their disclosures without accessing sensitive data or losing central visibility
• Enable central staff to monitor deadlines, compliance statuses, and submission completeness

Modular configuration

• Configure the system with region-specific modules or workflows so local affiliates see only what is relevant for their jurisdiction while the core functionality and data remain standardized

Why it matters

By centralizing data and workflows on a unified platform, organizations minimize duplicative tasks, enhance data consistency and accuracy, and maintain real-time visibility across all affiliates and CROs.

6. Training & culture

Standardize training & continuous engagement

Training curriculum & certifications

• Develop and deliver a structured training curriculum (e.g., e-learning, periodic “lunch-and-learn” sessions) to ensure consistent knowledge of global and local disclosure requirements.
• Offer “certification” for affiliates and CROs—reinforcing competence and accountability.

Regular touchpoints & feedback loops

• Host quarterly or semi-annual meetings with affiliates to review updates in disclosure regulations, share best practices, and discuss lessons learned.
• Conduct feedback sessions to capture local challenges early, allowing central teams to update SOPs or training materials.

Why it matters

A culture of compliance, bolstered by strong leadership support and shared success, drives consistent quality and continuous improvement across geographies.

7. Year-round oversight

Conduct periodic audits & quality checks

Global & local audits

• Perform periodic internal audits of selected disclosures to ensure consistency and accuracy
• Where CROs are involved, include disclosure compliance and the accuracy of standard data usage as key performance indicators in contract evaluations and renewal decisions
• Engages central quality assurance (QA) teams and local representatives to collaborate on corrective actions

Performance metrics

• Track metrics such as on-time disclosure and the number of findings from internal audits or inspections
• Use these insights to refine training, update SOPs, and recalibrate roles or responsibilities

Why it matters

Regular quality checks maintain ongoing vigilance, quickly detect gaps or inaccuracies, and foster a culture of accountability within both the central team and external partners.

Next Steps

This overview of the CLARITY Model lays the groundwork for a cohesive, globally coordinated clinical trial disclosure process. In Part 2, next week, we’ll look at a practical, phase-by-phase implementation timeline designed to translate these guiding principles into tangible, step-by-step actions. In the meantime, consider the following ways to deepen your understanding, assess your organization’s readiness, and engage with our team for tailored support:

1. Download our free eBook on the clinical trial disclosure maturity model to access a detailed review of the key stages organizations typically move through when evolving their disclosure processes, from ad-hoc local submissions to fully integrated global oversight. You’ll see how the CLARITY Model aligns with — and accelerates —each stage of maturity.
2. Take our free disclosure maturity self-assessment to discover your current level of disclosure maturity and identify the next steps needed to advance. This assessment pinpoints gaps and strengths and recommends tactics for improving central coordination.
3. Contact me for further guidance.?Every organization’s situation is unique. Feel free to reach out if you’d like to discuss your specific challenges or explore how we can help implement a centrally coordinated framework.
4. Like and share:?Please consider liking and sharing this article if it resonated with you or helped clarify your path to managing global disclosure.