In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel’s extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:
- Strategic Initiation & Planning – establishing a robust framework and standardized processes
- Comprehensive Preparation & Due Diligence – ensuring stakeholder alignment on transition plans and timelines – Conducting thorough documentation review and gap analysis
- Adaptive Execution & Transfer – How to operationalize a study transfer – Anticipating challenges and employing agile governance for real-time course corrections
- Effective Closure & Delivery – defining clear transition thresholds and success metrics – Ensuring continuity and maintaining data integrity throughout the process
Suzanne McNally, Executive Director in Portfolio Management, Parexel
Mitigating the environmental impact of clinical trials, in line with the broader imperative to address the interconnected climate and health crises.
During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table lead/host and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.
ROUNDTABLE 1:
| Enhancing Site Feasibility and Analytical Lab Testing: Strategies for Effective Communication and Sample Integrity |
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Kerri Fuller, Director, Resp/Imm/ID PM Operations, GSK
| ROUNDTABLE 2: Innovative approaches to support sites facilitate study implementation including EHR data mining, eISF, and SSO login |
Marie Lefebvre, Local Innovation Lead, Sanofi
| ROUNDTABLE 3: The role of lived experience in clinical trials: meaningful patient engagement in clinical trials is vital to develop impactful and relevant outcomes |
Cameron Keighron, Project Coordinator, International Diabetes Federation of Europe and Trials@Home consortium member, Patient Advocate
| ROUNDTABLE 4: MHRA draft guideline on the use of external control arms based on real-world data to support regulatory decisions
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Rebecca Ghosh, Real World Evidence Specialist, MHRA
| ROUNDTABLE 5: The EU CTR 536/2014, how is it going so far? Background, operational challenges, opportunities
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Riccardo Ferraiuolo, Sr Manager – Clinical Trials Transparency, Biogen
