As focus and momentum build to deliver clinical research in a more environmentally sustainable way, forecasting environmental impacts of individual studies and entire portfolios becomes increasingly important for trial leaders. This talk will present benchmark data and several extrapolation techniques to help clinical leaders facilitate discussions. An online estimation tool will be demonstrated live for the purpose of helping trial leaders articulate the environmental sustainability trade-offs of different study designs.

This talk will address current trends and best practices pharma and biotech companies are employing for site contracts, budgeting, and payments. We'll discuss common challenges, novel approaches, and strategies for examining your own current processes and areas for improvement.

Global unified contracting templates are standard in many pharma companies when conducting clinical trials. But is this approach sufficient as different countries worldwide follow different strategies? Legally prespecified contracts on a national or regional basis, healthcare system-orientated approaches, or sample contracts exist worldwide. This approach should improve start-up timelines and ensure a streamlined inclusion of patients. Also, the presentation will describe the benefits of this harmonized contracting approach between sites and sponsors.

In large pharmaceutical companies, the opportunities for advancement may be limited due to the availability of leadership positions, corporate siloing, and competition. In addition, exposure to the drug development process may be limited by function. Small biotech may offer an opportunity to use large pharma drug development and functional experience to gain further knowledge and expertise across functional areas leading to enhanced development and leadership opportunities. There is risk and a transition period when taking this leap. This presentation will focus on the differences between the work experience at a large pharma vs a small biotech, what to expect during the transition, and how to plan for success. Topics will include infrastructure, choosing a CRO, relationships, technology, culture, recruitment, hiring for success, and training and development of team members.

Clinical study success depends on three “C” or core elements: communication, collaboration, and cooperation from all participating individuals. When it comes to working on rare diseases, the chances of outsourcing to a CRO or vendor with prior experience in that particular indication are often nonexistent or quite limited. This presentation will focus on how Rezolute took a more direct, hands-on approach to executing a rare pediatric pivotal Phase 3 Global Program. How we removed divisions in vendor communication lines and instead led or joined the lines which helped facilitate site and vendor relationships, ultimately delivering faster outcomes and creating stronger and more cohesive study teams.

Running trials nimbly—utilizing in-house talent and managing a trial without a CRO. How to evaluate if this is the right model for you and look at the pros and cons for your team/organization. Which vendors and consultants will you need and which resources can be used from the company? Which processes and plans will need to be developed and which lessons learned?

Discover strategies for diverse clinical trial participation by developing inclusive protocol designs, applying data-driven site identification, and proactively customizing outreach and support for diverse populations. Attendees will learn strategies for determining trial-specific benchmarks and measuring success to enhance their ability to contribute to equitable and representative clinical trials.

This presentation on "Collaborative Partnerships" provides a glimpse into the exploration of collaborative partnership as a strategic avenue for operationalizing Diversity, Equity, and Inclusion (DEI) initiatives within organizations and even our healthcare system. The focus is on forging inclusive alliances that contribute to the effective implementation and integration of DEI efforts. We can approach this from case studies, best practices, and practical insights, which this presentation seeks to shed light on the transformative potential of collaborative partnerships in creating a more diverse, equitable and inclusive organizational culture and environment. This brief presentation will attempt to delve into key considerations, challenges, and success factors in establishing and nurturing these alliances, emphasizing the role of outsourcing and external partnerships in advancing DEI goals. Ultimately the goal is to provide a fair understanding of how organizations, such as sponsors, CROs, and clinical trial research centers can leverage collaborative partnerships as a powerful tool for operationalizing DEI initiatives and fostering sustainable positive change as we work together to better the lives of all citizens, regardless of race, religion, or ethnicity.