Navigating the New Frontier of Data Governance in ICH E6 R3 - A Strategic Insight from SDC Clinical

Recently, at the Arena OCT East Coast conference in King of Prussia, PA, SDC had the pleasure to hear from Cat Hall in her presentation on Establishing data governance as a best practice in your clinical eco-system. In the ever-evolving landscape of clinical research, the imminent changes in ICH E6 R3 present both challenges and opportunities for organizations striving to maintain the integrity and compliance of their data. As these revisions loom on the horizon, the importance of robust data governance has never been more pronounced.

At SDC, we provide fit for purpose software, technology services, and quality support in the clinical research domain, and stand out as an innovator in validated software for the transformation that R3 will bring. With an understanding of the intricacies of data governance, SDC Clinical is poised to offer unparalleled technical and quality support to organizations navigating the complexities of ICH E6 R3.

The Pillars of Data Governance in the Wake of ICH E6 R3

The revision of ICH E6 R3 underscores the necessity for a comprehensive approach to data governance. In fact, section 4 in the draft of the new revision specifically introduces data governance in a way not previously emphasized in R2. This encompasses a strategic alignment of policies, processes, and technologies to ensure the accuracy, availability, and protection of critical data throughout its lifecycle.

As we heard in Hall’s presentation, there is a specific emphasis placed on the full data lifecycle that goes beyond the collection of data. To support a lifecycle approach, SDC places emphasis on the following pillars as a foundation of effective data governance to support ICH E6 R3:

1. Quality Management System: Implementing a comprehensive quality management system which Includes risk management, change management, monitoring and continuous improvement.
2. Strategic Alignment: Aligning data governance strategies with organizational objectives to ensure seamless integration and support for the new requirements.
3. Regulatory Compliance: Staying abreast of regulatory changes and implementing governance frameworks that not only comply with but anticipate future requirements.
4. Data Quality and Integrity: Ensuring the accuracy and consistency of critical data and data processes, which is paramount in the context of clinical research and its regulatory scrutiny. This Includes the use of validated systems to ensure data Integrity and reliability as well as traceability and protection of personal information
5. Risk Management: Prospectively identifying and mitigating serious risks associated with data management, including those introduced by the new ICH E6 R3 revision. This Is an iterative process to ensure risks are appropriately managed throughout the data lifecycle.
6. Vendor Management: Managing vendors and other clinical trial stakeholders to ensure they adhere to the stringent data governance standards required by ICH E6 R3.

SDC Clinical's Expert Services

SDC Clinical offers a suite of expert services designed to guide organizations through the turbulent waters of ICH E6 R3's data governance requirements:

• Consultative Expertise: SDC Clinical's team of experts provides strategic technical, regulatory and quality consultation to help organizations understand and implement the necessary changes brought about by ICH E6 R3.
• Regulatory Navigation: With a deep understanding of regulatory requirements, SDC Clinical assists in navigating the complex requirements of ICH E6 R3 throughout the clinical study from concept through submission.
• Data Management Solutions: Offering state-of-the-art validated data capture and management solutions that are compliant with the latest regulatory standards.
• Training and Education: Empowering organizations with the current knowledge and skills required to uphold the principles of data governance in the new regulatory environment.
• Continuous Support: Providing ongoing technical and quality support to ensure that data governance strategies remain effective and compliant over time.

Embracing Change with Confidence

The revisions in ICH E6 R3 present an opportunity for organizations to reassess and strengthen their data governance frameworks. With SDC Clinical's expert services, organizations can embrace these changes with confidence, ensuring that their data governance strategies are not only compliant but also strategically positioned for the future.

As we step into this new era of clinical research ushered in by ICH E6 R3, let SDC Clinical be your key quality and technical partner in mastering the art of data governance, turning regulatory challenges into strategic opportunities.