Clinical development executives from across the Philadelphia and southern New Jersey area gathered April 23, 2014, in Malvern, PA, to share best practices, discuss challenges, and network with industry colleagues. The meeting took place as part of the nationwide Clinical Power Lunch (CPL) series sponsored by Imperial Clinical Research Services, Biomedical Systems and PRA.
Now in its fourth installment, the CPL provides a regional forum for drug development executives to gather and share real case studies and actionable advice with one another in a casual and friendly environment. Event highlights include a complimentary gourmet lunch for all attendees, social periods, and presentations on timely and relevant industry topics.
The Malvern event featured three presentations, all of which were well-received and sparked interactive Q&A sessions and post-presentation discussions. Following is a summary:
1. Best Practices & Common Pitfalls to Avoid in Planning Country and Site Selection … Focus on: Study Feasibility, Site Selection and Patient Recruitment ─ My presentation shared common challenges faced by clinical research management when planning and conducting global clinical trials. These included challenges directly related to enrollment optimization, regulatory application, study feasibility as part of country selection and site selection, and relationships with clinical investigators. I also provided a variety of proactive solutions to avoid similar challenges on future studies.
2. Risk-Based Monitoring – Maria Harrison, vice president of Late Phase Services at PRA, gave an informative talk on strategies for ensuring that risk-based monitoring (RBM) aligns with regulatory/industry guidance and meets the unique needs of clinical trial sponsors. PRA provides a flexible, guided approach to RBM that addresses each phase of sponsor implementation as they transition from 100 percent SDV to full RBM.
3. Benefits of Centralized Imaging in Early Phase Trials ─ Presented by Angie Petroff, Nuclear Medicine project manager at Biomedical Systems, this discussion centered on the benefits of incorporating imaging data into early phase oncology trials. Among the advantages are providing efficacy information using functional assessments, and helping to determine how to proceed with the next stages of investigation.
The event concluded with some dedicated time for discussions among attendees, which one observer noted were characterized by “noisy, enthusiastic and active dialogue.”
Were you invited but unable to attend the CPL? Send an email to connect@imperialcrs.com to receive a copy of the presentation, ask questions, or set up an individual meeting with one of our representatives.
Stay tuned to www.imperialcrs.com for news on upcoming events.
