Archives: Agenda

Sponsored by Suvoda

• 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

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.

This panel will take place in TRACK A: Outsourcing & Clinical Operations

1 stage, a variety of rapid-fire opinions, bold predictions and myth-busting from experts across the industry. Audience members will vote, agree or disagree, on each hot take! There’ll be a chance for the audience to pose some questions to the panel too.

The panel will answer the following:

• Biggest mistake in clinical trials today
• One thing pharma should stop doing
• One prediction for 2030
• What’s overhyped and what’s worth the hype
• What vendors misunderstand
• Where trials fail most often
• Biggest recruitment mistake
• Hot takes from the audience

Moderator: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

• 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

• Identify protocol risks earlier through integrated clinical, operational and site-level perspectives.
• Design more executable studies by aligning protocol ambition with real-world site and patient needs.
• Reduce avoidable delays, amendments and costs by building feasibility into the protocol from the outset.

• The Adult-Pediatric mediation gap in Immunology
• Barriers to clinical research in children
• How CROs provide solutions to the obstacles of pediatric clinical research

Sponsored by EmVenio

• Bringing the site voice to study design: Partnering with investigators during protocol development to reduce amendments, deviations, and operational friction
• Preventing problems before they happen: Using real-world site feedback to proactively adjust study design and execution
• Acting as the connective driver between sponsor, CRO, and sites to ensure alignment, accountability, and continuity across the trial lifecycle
• Lessons from a lean biotech: Stepping beyond defined roles and filling operational gaps, ensuring data flow and maintaining patient safety
• Redefining success by measuring the unquantifiable impact of strong site relationships on recruitment, retention, and overall trial performance