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The FDA’s draft guidance, ICH E6 (R3), focuses on computerised systems and has had more than 7,000 comments to date that are currently being incorporated into a final guidance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.
In this section
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Digital Disruption
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
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Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Flexible delivery models
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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