Archives: Agenda
Registration
PANEL DISCUSSION: Where is the clinical trial industry headed?
- Moving studies forward on unknown territory: Funding clinical trials amidst recent research policy changes and abrupt NIH cuts
- Shining light on the changing scope of the FDA: Discussion of the latest changes under the new administration including years of critical DEI work
- Technological developments into 2026 and beyond: what changes can we expect to see in the next 3-5 years?
- Navigating the constantly evolving vendor and CRO landscape as a small to mid-sized sponsor company
Moderator: Robert Loll, SVP, Business Development & Strategic Planning, Praxis
From sample to strategy: Holistic laboratory partnership to enable delivery of modern trial designs
- Integrating central lab expertise early in trial design to avoid fragmented workflows and costly delays
- Enhancing trial efficiency and biomarker strategy through proactive collaboration with laboratory partners
- Positioning lab providers as co-authors of research success, offering insights on biomarkers, assays, sample logistics, and data flow
- Ensuring protocols are both scientifically robust and operationally feasible by embedding lab considerations from the outset
FDA’s Office of Import Operations (OIO): Updates and tips for supporting importation of safe and quality FDA-regulated products
- Organizational Updates
- Nationalized Entry Review
- Pharmaceuticals import and entry transmission compliance requirements
- Biologics import and entry transmission compliance requirements
Lunch and Networking
A comprehensive site support model for complex trials
- Today’s clinical trials are becoming more complex, trending towards patient-centric approaches and biomarker-driven designs
- Higher burdens are put on sites and patients to adhere to the protocols
- We present a comprehensive site support model that reduces burdens on investigators, site clinical research staff and patients, increasing protocol compliance and data quality.
Not all site networks are created equal: A Sponsor’s guide to smarter site partnerships
- Understand what often goes unseen in site networks, including turnover, burnout, and uneven site support, and how these issues impact delivery
- Learn how to evaluate CRO and network partners beyond surface-level metrics like site count and start-up timelines
- Explore why sustainable site relationships depend on consistency, communication, and shared goals rather than financial incentives alone
- Hear real-world insights into the operational strain sites face and how sponsors can better align with what sites truly need to succeed
- Gain a more realistic, strategic framework for assessing site networks before outsourcing decisions are made
Study start-up challenges in a competitive environment
- Overcoming financial constraints when budgets are limited and resources tight
- Fierce site competition: How start-ups can compete with established companies for sites
- Utilizing effective planning to improve study and program efficiency without compromising patient safety
- Agile and adaptable: Being prepared to adjust your strategy and approach as needed
PATIENT SPOTLIGHT: Ethical requirements and rights for patient disclosure and consent when implementing AI tools
- How do we look at data transparency issues when scaling AI?
- Case study on AI rights and a look at recently released survey discussing where things need to change
- Without GDPR, what can be done to protect patients regarding data sovereignty?
- Delving into the unique and amplified challenges for AI risk assessment
- How can we effectively leverage AI in our heavily regulated environment?