In this edition of the Quality Issue...

...we’re exploring key topics that can elevate your clinical data management strategies.

? Discover why joining the Association for Clinical Data Management (ACDM) can provide invaluable resources, career growth opportunities, and a strong professional network.

? Take a deep dive into Centralized Monitoring; uncover why this proactive approach is no longer just best practice, but an essential industry standard for ensuring data quality and patient safety.

The Association for Clinical Data Management (ACDM)

What?

• ACDM is a professional organization dedicated to advancing the field of clinical data management.
• The association plays a key role in promoting best practices, developing industry standards, and fostering collaboration among data management professionals.

Why?

• Access to Expert Resources: Stay informed with industry insights, guidance documents, and training programs.
• Networking Opportunities: Connect with professionals across the clinical data management community.
• Career Development: Gain new skills, expand your knowledge, and enhance your career prospects.
• Industry Events: Attend conferences, webinars, and workshops to stay up to date on emerging trends.
• Supportive Community: Be part of a collaborative network that encourages learning and growth.

Who?

• ACDM is ideal for anyone involved in or interested in clinical data management and clinical research. This includes:

o?? Clinical Data Managers

o?? Clinical Research professionals

o?? CRO employees

If you're considering it, now's the time to get involved and take advantage of everything ACDM has to offer.

?? Don't miss out - join ACDM here!

Centralized Monitoring: The Key to Proactive Risk Management

In today's fast-evolving clinical trial landscape, ensuring data quality and patient safety is more critical than ever. One of the most effective ways to achieve this is through centralized monitoring, a powerful tool that enables clinical teams to detect risks early and act proactively.

Why Centralized Monitoring Matters

Traditional site monitoring methods often rely on scheduled visits and manual data reviews, which can result in delayed detection of issues. Centralized monitoring, on the other hand, leverages real-time data analysis to identify potential risks across trial sites without the need for frequent on-site visits. By using advanced analytics, teams can efficiently track data trends, spot anomalies, and focus resources where they are most needed.

To maximize the benefits of centralized monitoring, consider these key practices:

• Define Key Risk Indicators (KRIs): Identify critical metrics such as protocol deviations, data inconsistencies, or safety concerns. Tracking these in real-time allows you to act before issues escalate.
• Track Key Metrics: Focus on data points that highlight potential risks, such as:

o?? Data entry delays

o?? Unexpected trends in adverse event reporting

o?? Unusual patterns in lab results

o?? High rates of missing or inconsistent data

• Leverage Data Visualization Tools: Interactive dashboards and visual analytics provide clear insights into data patterns, making it easier to detect emerging risks.
• Establish Clear Escalation Pathways: Ensure your team has clear processes for investigating and resolving issues flagged through centralized monitoring.
• Train Your Team: Equip your staff with the knowledge and skills needed to interpret data signals and respond effectively.

Success in Action

A recent Phase III oncology trial faced challenges with inconsistent reporting of adverse events across multiple sites. By implementing centralized monitoring, the sponsor identified data discrepancies early, prompting a targeted review at specific sites. This proactive approach ensured the safety of trial participants while preventing delays in study timelines.

Looking Ahead

Centralized monitoring is no longer just a best practice - it’s becoming an industry standard. By adopting this proactive approach, clinical teams can improve data quality, enhance patient safety, and optimize trial outcomes.

Are you ready to harness the power of centralized monitoring? Our team is here to help you implement strategies that align with your RBQM framework. You can find details of our reimagined, industry leading Centralized Monitoring technology, OPRA-CM here.

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Coming up:

?? SCDM EMEA 2025 – Brussels | 09-11 April

We're excited to announce that we'll be exhibiting at SCDM EMEA 2025 in Brussels! If you're attending, we'd love to see you there.

?? Visit us at Booth 21

Stop by to: ? Chat with our team about all your RBQM questions and queries ? Pick up some fantastic free merch ? Connect with fellow clinical data management professionals

The SCDM EMEA Conference is the must-attend event for clinical data managers in the region. It’s an opportunity to engage with peers and other key stakeholders in the industry, including policymakers, regulators, site representatives, and patient organisations. It’s where the leading minds in clinical research gather to influence the future of the industry. If you’re not yet on the list, you can register here

We look forward to meeting you in Brussels - see you there!

If we don’t see you at SCDM, thanks for reading, see you in April for the next edition of The Quality issue. ??