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ICON at SCDM 2024

Connecting the dots of clinical data management

This year’s Society for Clinical Data Management (SCDM) conference was the largest European conference in their 25-year history. Held 17-19 April 2024 in Warsaw, Poland, SCDM EMEA had well over 300 attendees from 27 countries come together to share invaluable knowledge that helps to strengthen our clinical data management community and industry. 

The 2024 EMEA conference theme was cross-collaboration and its ability to drive innovation in clinical data science. There were a number of engaging sessions across the conference with key highlights around:

  • ICH E6 (R3) key foundational principles that support risk proportionality and inspection finding examples
  • Change management and adaptation as a constant in clinical trials
  • Artificial intelligence (AI) as an integral part of clinical research futures
  • Using intuition to improve the human experience 
  • Cross-functional and cross-organisation RBQM education 
  • Early engagement of CDM/Programmers in protocol design 

Fast-paced keynote: F1 and the Five Vs

Paddy Lowe, CEO of ZERO Petroleum gave the keynote address, later joined by Tanya DuPlessis, Chief Data Strategist and Solutions officer at Bioforum the Data Masters, and Christopher Lamplugh, Head of Global Data Management and Standards at Merck. As former Technical Chief Engineer of Formula One (F1) teams Williams and Mercedes as well as Technical Executive Director of McLaren, Lowe shared insights paralleling the fast-paced, high stakes of F1 and data science, including that new data can inspire new innovations. He painted a thrilling picture of the 2016 Brazilian Grand Prix, a rain soaked race where all data pointed to a tapering off of the bad weather, but the immediate evidence in the puddle at his feet informed a different decision – one that was ultimately the right call. 

As illustrated in the F1 analogy, some data matters more in targeted cases and stakeholders will have varied uses. The keynote speakers discussed the connection of the Five Vs in data: volume, velocity, variety, veracity and value. 

Notes from the regulators: ICH E6 (R3)

Regulators also shared some valuable insights including the importance of data flow diagrams in your Data Management Plan and the potential safety ramifications of not catching a dose tapering programming error. 

The FDA’s draft guidance, ICH E6 (R3), focuses on computerised systems and has had more than 7,000 comments to date that are currently being incorporated into a final guidance document. The guidance expands on key principles supporting risk proportionality in data governance. 

ICON in conversation at SCDM EMEA

As an industry leading CRO powered by healthcare intelligence, ICON’s experts were eager to share their knowledge and insights. We were represented by four speakers across four separate panels. 

 

Transforming trials with RBQM as the connective tissue for data quality 

Elena Zaffaroni, Senior Director Clinical Risk Management

This panel explored the importance of a common understanding of risk based quality management (RBQM) across teams and organisations and outlined elements of a holistic approach to achieving unified, data-driven decision making. 

 

Clinical Data Manager testimonials

Sam Ryan, Director Clinical Data Science

The speakers discussed the increasing importance of having the right people in clinical data management (CDM) roles as they set standards for data quality and steer adaptation to innovative technologies and changing data collection and validation methodologies. ICON’s Sam Ryan shared his experience in this rapidly evolving environment and contributed deeper insight into what keeps CDMs motivated in this dynamic, challenging role. He also expressed the benefits of mutual mentorship between managers and their employees as attitudes and strategies for using and learning technology can vary greatly, and there are opportunities for adopting new perspectives. 

 

Championing change: Mastering agile and change management strategies for the successful adoption of transformational projects

Anjali Nadubailu, Senior Manager

Change management experts shared key drivers for success to ensure their organisations can navigate the complex challenges inherent in transformation projects. This session was geared toward practical knowledge-sharing, allowing attendees to learn strategies, skills and lessons from change management professionals to help drive impactful changes in their organisations. 

 

Data management as leaders in DEI and cultural awareness: How we can fuel global collaboration, build healthy organisations, and meet the needs of the humans behind CDM 

Stephen Cameron, Director Clinical Data Science

Effective collaboration and ultimate organisational success require strategic imperatives for diversity, equity and inclusion (DEI) to empower employees to showcase their diversity and attract top talent that enriches the organisational culture. The speakers dove into the ways cultural awareness and dedication to engaging with DEI can cultivate an inclusive workplace and ultimately transform it for the better. 

Magic moments of learning at SCDM

During the closing plenary led by Richard Young (Veeva), we imagined magic – what, in our view, would we want to magically appear or disappear? There were many interesting answers, some humorous, some compelling. Ultimately, the exercise encouraged us all to envision the future of our field and clinical research; automatic connectivity between all systems, mind-reading machines that generate the appropriate tools, site-to-site teleportation, disease eradication. Creative solutions to complex challenges may start as a blue-sky, magic wish conversation, but the knowledge exchanged in conferences like SCDM and the conversations and excitement we share help drive us closer to real solutions. 

We were glad to participate at SCDM EMEA 2024 and look forward to next year’s conference in Brussels, Belgium. 

To learn more about the innovative solutions we already offer, connect with us today. 

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