Balancing Global Standards & Local Autonomy: The CLARITY Model for Clinical Trial Disclosure

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.

Implementation timeline

Transitioning from a decentralized approach to a centrally coordinated disclosure requires a high-level plan. Below is a proposed nine-month roadmap outlining the key milestones and tasks required to transition from a decentralized clinical trial disclosure approach to a centrally coordinated model. Divided into distinct phases, from governance and SOP revisions through technology deployment and performance measurement, this timeline provides a structured blueprint for organizations looking to improve consistency, reduce compliance risks, and streamline the disclosure process across all regions.

Phase 1 (months 1–2): Strategy & governance

Goal: Establish the foundation for a centralized model

• Form a disclosure governance body (center of excellence)
  • Identify cross-functional stakeholders (regulatory, clinical, IT, legal, etc.)
  • Assign clear roles, responsibilities, and project leadership
• Conduct current-state assessment
  • Review existing SOPs, tools, and responsibilities for each affiliate/CRO
  • Pinpoint critical gaps in compliance, data consistency, or technology usage
• Define project scope & objectives
  • Outline what “centrally coordinated” means for your organization (e.g., specific SOPs, technology changes, compliance metrics)
  • Draft a high-level change management plan to align teams on upcoming transitions

Phase 2 (months 3–4): SOP refinement & contract updates

Goal: Create standardized processes and formalize partnerships

• Update or draft new global SOPs
  • Incorporate standardized datasets, training requirements, and escalation pathways
  • Allow local affiliates to add country-specific work instructions where needed
• Revise contracts & expectations with CROs
  • Add explicit disclosure timelines, reporting obligations, and quality/compliance metrics
  • Clearly define which party (sponsor vs. CRO) handles specific tasks (e.g., data entry, results posting, etc.)
• Identify & configure technology needs
  • Implement or upgrade existing solutions (e.g., expanded use of TrialScope Disclose and TrialScope Intelligence) or add new data integrations
  • Define core data fields and reporting workflows for local affiliates

Phase 3 (months 5–6): Pilot & training

Goal: Test the new framework and prepare teams for broader adoption

• Select a pilot region or therapeutic area
  • Test updated SOPs, technology tools, and contract language on a smaller scale to gather feedback
  • Track key performance indicators (e.g., on-time disclosures, data accuracy)
• Deliver targeted training
  • Roll out foundational training for affiliates and CROs (SOP changes, contract terms, new technology features)
  • Provide “train-the-trainer” sessions for local/regional champions who will support the rollout
• Collect feedback & refine
  • Host debrief sessions to identify what worked or needs adjustment
  • Update SOPs, training materials, and system configurations before the global launch

Phase 4 (months 7–9): Full rollout & system integration

Goal: Deploy the centrally coordinated model across all regions

• Global technology deployment
  • Launch the integrated platform or expanded system modules globally (role-based access, dashboards, automated reminders)
  • Ensure local affiliates and CROs have secure logins and the final data collection forms, such as the TrialScope Core Disclosure Form
• Implement updated SOPs & contracts
  • Enforce new or revised contracts, ensuring that disclosure timelines and responsibilities are clear
  • Monitor any local affiliate or CRO issues that surface and troubleshoot promptly
• Maintain ongoing communication & support
  • Conduct regular project status calls to address questions and reinforce best practices
  • Maintain a helpdesk or designated support contact for quick issue resolution

Phase 5 (post implementation): Optimization & measurement

Goal: Establish continuous improvement and measure early outcomes

• Conduct initial audits & quality checks
  • Review a sample of newly completed disclosures to gauge compliance, data accuracy, and on-time posting
  • Use this data to pinpoint persistent gaps or training needs
• Measure key metrics
  • Compare actual performance to baseline (e.g., on-time disclosure rates, error rates, etc.)
  • Share findings with senior leadership and local teams to reinforce accountability
• Refine & scale
  • Based on audit results, refine SOPs, training materials, or technology configurations
  • Plan further enhancements (e.g., automated data integrations, advanced analytics) in the next iteration

This timeline can be accelerated or stretched depending on the organization's size, available resources, and the urgency of managing compliance. However long the transition is planned for, by dividing the transition into clear phases and milestones, sponsors can gradually align teams, reinforce best practices, and successfully operationalize a centrally coordinated clinical trial disclosure model.

Looking Ahead

Organizations can incrementally evolve their disclosure practices by combining a robust governance structure with a pragmatic “hub-and-spoke” model, balancing local autonomy with global standards. Strengthened by global SOPs and technology (deployed in phased, manageable increments) and a supportive culture of compliance and accountability, sponsors can achieve timely, accurate, and consistent global clinical trial disclosures. Distributing approved standard datasets further aligns disclosure across all regions, protecting company confidential information (CCI) and patents while driving high-quality, transparent reporting for stakeholders worldwide. This approach leverages the expertise of local teams while unifying compliance strategy under a cohesive, enterprise-wide framework.

With the CLARITY Model — Central governance, Local empowerment, Accountability & SOPs, Roadmap for improvement, Integrated technology, Training & culture, and Year-round oversight — organizations can solidify a global disclosure strategy that harmonizes compliance requirements with the agility of local affiliates.

Next Steps

While the CLARITY Model and implementation roadmap offer a practical path toward centralized clinical trial disclosure, organizations vary in starting points and specific needs. Understanding where you fall on the “maturity” continuum helps you tailor these strategies effectively and measure progress over time. Here are a few ways to dive deeper and act:

1. Download our free eBook on the clinical trial disclosure maturity model
   Gain a detailed overview 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
   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. I’m happy to offer tailored insights and strategies.