Cambridge Healthtech is organizing the sixth annual Summit for Clinical Operations Executives in Barcelona: SCOPE Europe 2023, the premier healthcare conference for clinical operations in Europe.
This year’s SCOPE Europe 2023, taking place on October 17–18, will cover a wide range of topics, including feasibility, site selection, study activation, enrollment planning, participant engagement, recruitment, risk-based quality management, monitoring, clinical data technology for digital and hybrid trials, and emerging regulations.
Anju Software CEO Laurence Birch will deliver the chairperson’s remarks to kick off the Feasibility, Site Selection and Study Activation program on the morning of Tuesday, October 17. The most critical components of the clinical trial process include early development planning, feasibility assessment, protocol development, and site selection. Performing these first steps effectively will significantly impact the likelihood of completing the trial on time and within budget. Novel approaches to stakeholder communication and collaboration together with innovative data and analytics capabilities, new protocol development and feasibility assessment processes are improving clinical trial timelines and outcomes and driving trial success.
There’s a lot to digest in two days.
Below are five sessions we’re looking forward to at SCOPE Europe 2023, the leading healthcare event for clinical operations executives.
Presentation: Patient Voice Methodology to Choose to Obtain the Appropriate Protocol-Specific Insights
Tuesday, October 17
9:25 a.m.
Janssen Pharmaceuticals’ Director of Patient Insights Alyson Gregg and Lieven Van Vijnckt, Head of IPE TA for Infectious Disease and Vaccines at Janssen, will present two methodologies their company has used to obtain the insights researchers need at specific stages of clinical development.
As clinical researchers know very well, capturing the authentic voice of the patient is a key driver of innovation in the pharmaceutical industry and clinical trials. We are excited to hear what Gregg and Van Vijnckt have learned through these patient-centric approaches, and how it can shape the future of healthcare innovation.
Panel: Navigating Global DCT Adoption — Driving Change through Collaboration
Tuesday, October 17
12:35 p.m.
In this decade alone, we have seen rapid advances in decentralized trials, the supporting technology, and patients’ experience.
Craig Lipset, Founder and Advisor at Clinical Innovation Partners and Co-Chair of the Decentralized Trials & Research Alliance (DTRA), will lead a panel discussion on how researchers are leveraging the power of the DTRA’s Regulatory Conduct Map as a shared single source of truth to guide their work.
These insights shed light on the dynamic landscape of decentralized clinical research, the role of technology in shaping its future, and the importance of a patient-centric approach.
Panelists will include:
- Dylan Bechtle, Associate Director of Regulatory Policy and Intelligence at Janssen.
- Megan Heath, Vice President and Europe Region Head of Sanofi’s Clinical Studies Unit.
Panel: From Concept to Reality — The eSource-to-EDC Revolution Gathers Pace
Wednesday, October 18
11:30 a.m.
Electronic data capture (EDC) stands as a pivotal technology in modern clinical research today.
Mats Sundgren, Senior Industry Scientific Director at the European Institute for Innovation Through Health Data (i-HD), will lead a panel discussion on the opportunities and challenges associated with harnessing clinically-validated Electronic Health Records (EHR) data and seamlessly transferring it through EDC systems.
Panelists will include:
- Peter Casteleyn, Director of Clinical Data Collection Solutions-EHR at Janssen.
- Paul Jacobs, Associate Director of Development Innovation at Regeneron Pharmaceuticals.
- Joe Lengfellner, Senior Director of Clinical Research Informatics at Memorial Sloan Kettering Cancer Center.
Together, they will delve into the complexities of data integration, the latest trends in clinical data collection, and the innovative solutions driving healthcare technology forward.
Case Study: Nestlé’s Fully Decentralized Study on Ketogenic Treatment for Migraines
Wednesday, October 18
2 p.m.
Inez Sroda, Associate Clinical Project Manager at the Nestlé Research Center, will present a case study on the organization’s completely decentralized study on ketogenic treatments for migraines.
This case study stands out as a remarkable example because every aspect of this trial — from patient screening to study visits — was conducted remotely. Despite the compelling advantages of decentralized studies, some sponsors remain hesitant due to perceived complexities or a lack of experience in conducting trials of this nature.
Sroda’s case study promises to offer a compelling argument addressing these objections and will shed light on the future of decentralized use in studies and trials.
Case Study: RbQM Application in ePRO Primary Endpoint Clinical Trial
Wednesday, October 18
2:25 p.m.
Two researchers from AstraZeneca — Tomasz Foks, Associate Director of RbQM Centralized Monitoring, and Adam Wawro, Senior Clinical Data Scientist II — will present this case study in ePRO instruments and their reliability in the face of deteriorating patient compliance over time.
Foks and Wawro will delve into the advantages of risk-based quality management (RbQM) implementation, emphasizing how centralized monitoring strategies can effectively control defect rates in clinical trials. Their presentation promises to shed light on the critical role of RbQM and centralized monitoring in ensuring the quality and reliability of patient-reported data in clinical research.
Join Anju at SCOPE Europe
Join us at SCOPE Europe in Barcelona to learn about the latest and greatest innovations and insights in clinical operations. Use code ANJU to receive 200 Euros off your registration rate.
Anju’s eClinical and Data Science teams will also be present there. Book a meeting with our experts or visit them in booth #16 if you want to see live how Anju’s technology solutions can help accelerate the execution and management of your clinical trials.
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