Archives: Agenda

For sponsors and biotechs, momentum is everything but data privacy gaps have a way of surfacing at the worst possible moment in extremely costly ways. This session walks through three checkpoints where privacy oversights can bring progress to a halt: regulatory submission, site-level execution, and the eventual sale or licensing of trial IP.

• Submission: the privacy documentation and registration gaps that can delay or derail regulatory filings
• Site: where data protection responsibilities between sponsor, CRO and site most often break down
• Sale: why buyers and licensing partners are scrutinising data provenance and privacy compliance more closely, and how gaps can devalue or derail a deal

QUIPMENT

• Aligning advocacy and industry to shape better trials that reflect the real world
• Protecting patient rights in an increasingly data-driven trial environment, from informed consent and data ownership to transparency over how patient data is collected and shared
• Balancing the use of patient data and AI with transparency, trust, and patient control to ensure new technologies enhance rather than complicate the patient experience
• Moving beyond standardized touchpoints to deliver more responsive and human-centered patient support

• Bringing the patient voice into every stage of development and embedding patient advocates from day one, moving from feedback to true co-creation across the trial lifecycle
• Breaking down barriers in access, diversity, and language to expand participation, build trust, and make trials truly patient-centered
• Simplifying participation and communication to reduce burden, improve understanding, and generate richer, more meaningful data
• Leveraging patient experiences to help change the landscape, making clinical trials better for patients worldwide

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• Effectively championing adaptive trial designs to stay nimble as the clinical research landscape continues to evolve
• Streamlining protocol finalization, regulatory submissions, and feasibility assessments to shorten start-up timelines
• Identifying and engaging the right sites as part of a broader operational readiness strategy
• Coordinating cross-functional teams, vendor partnerships, and internal stakeholders to ensure smooth study initiation
• Implementing robust onboarding, training, and communication plans to set the trial up for success from day one
• Reducing contract cycle times to accelerate study start-up

Moderator: Michael Murphy, Director, Legal & Associate General Counsel, Ionis

Sponsored by Suvoda

With drinks and refreshments, interactive breakout sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run twice and be led by a table moderator and will focus on a different challenge within clinical trials. Breakout discussions are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

• Better RFP specifications lead to better proposals, pricing, timelines, and accountability.
• The protocol is not the specification, define the operational assumptions CROs need to price and plan accurately.
• Separate requirements, assumptions, and CRO recommendations so proposals can be compared consistently.
• Standardize bid grids and key assumptions while still allowing CROs to propose differentiated solutions.
• Surface exclusions, dependencies, and hidden assumptions early, these are often the source of future change orders.
• Build uncertainty into the RFP with scenarios for sites, countries, enrollment, timelines, and amendments.
• Use the RFP and bid defense to test how the CRO thinks, not just what they charge.
• Carry proposal commitments into the contract, governance plan, KPIs, and operating model.
• The goal is not simply a better bid, it is better communication, fewer surprises