Breakout Session V & VI – Business Development
One-hour sessions with multiple topics relevant to your site’s success and sustainability will be presented for your selection. All sessions include active participation with either moderated panels or esteemed presenters that will provide many valuable takeaways.
Business Development (BD) & Recruitment & Retention (RR)
1:30 – 2:30
Future Therapeutic Trends: Considerations When Expanding into New Indications
Looking to expand into other therapeutic indications? Your business development must extend beyond your usual efforts and feasibility questionnaires. As pipelines shift direction and new therapeutic area opportunities are identified, discover what proactive steps can be taken to diversify your therapeutic portfolio and position your site as a leader in your desired field.
2:30 – 3:30
Sustaining Patient-Centricity Amidst Adversity
Achieving patient centricity is easier said than done, yet it is important that all stakeholders strive to remain patient-centric even when the going gets tough. This session will highlight how stakeholders maintained patient centricity through the COVID-19 pandemic, including strategies deployed and the resulting outcomes.
Budgets, Contracts & Finance ($)
1:30 – 2:30
Hidden Costs: Remote Monitoring & How to Budget for It
As industry continues to embrace and transition to remote monitoring, the potential staffing and financial burdens on sites mount. This session will help you evaluate the costs and value-add of remotely monitored trials, and understand what line items to keep in mind when negotiating study contracts and budgets.
2:30 – 3:30
Lessons from the Trenches: How COVID-19 Reshaped Study Budgets
The entire world, including the clinical research industry, has been turned upside down by the COVID-19 pandemic. With trials halted or closed to new enrollments, increased remote monitoring, staff lay-offs and more, we have entered a new paradigm that we must learn to navigate. Looking in the rearview mirror shows us new budget considerations that must be accommodated. This session will help you navigate “the new normal” so you are prepared and informed in the future.
Site & Study Operations (OPS)
1:30 – 2:30
Are Your Key Performance Indicators Aligned with Sponsor Expectations?
What are key performance indicators (KPIs), and how can they be utilized to operationalize your site and successfully market your strengths to sponsors and CROs? Join this session to learn how to ensure your KPIs are aligned with sponsor expectations and how to engage them in marketing efforts.
2:30 – 3:30
What Sponsors are Really Looking for in Your Site Feasibility Surveys
You’ve found the perfect study for your site, and you completed the site feasibility survey on time…just to find out two weeks later that you didn’t make the cut. Why? What additional information or tactics would have improved your odds? Participate in an interactive feasibility exercise to help you better understand what sponsors and CROs are looking for and what sites should know when completing feasibilities.
Regulatory & Compliance (REG)
1:30 – 2:30
Risk-Based, Centralized, Remote Monitoring, Say What? Quality Control, Explained
If centralized and remote site monitoring (RSM) were not yet on your radar, the COVID-19 pandemic brought it to your doorstep. But what exactly are they and what do they mean for sites? Further, how does all this relate to risk-based monitoring (RBM)? In this session you will hear lessons learned from experience and understand what sites should expect as a site from the future of monitoring.
2:30 – 3:30
2020 Vision: Clinical Research Trends & Changes From a Regulatory Perspective
The 2018 common rule foresees a single IRB review for multi-center trials, and the FDA is expected to follow suit. However, COVID-19 drastically changed how clinical research is managed. Trends and changes in clinical research will discussed from a regulatory perspective in this informative session.
