Conference Schedule

Negotiations between sites, sponsors, and CROs are often time-consuming, but there are strategies to accelerate this process and reduce timelines. Challenges such as indemnification, data rights access, and subject injury clauses are common sticking points that can delay activation. How can your team navigate these complex issues more efficiently to expedite negotiations?

  • Analyze the main issues that lead to slowdowns
  • Expand on how sponsors, sites, and CROs can contribute to achieve a faster timeline
  • Discuss how tools like templates and streamlined communication can accelerate the process
Speakers:

The rise of hybrid and decentralized clinical trials has improved patient retention and expanded access, especially for those in rural areas, by enabling in-home care and reducing travel burdens. However, this shift places significant responsibility on site investigators, who remain legally accountable for overseeing third-party vendors like home health agencies. While the FDA Draft Guidance on Decentralized Trials highlights general trial conduct, it doesn't fully address the oversight challenges posed by these vendors. This session will review the guidance, explore the complexities of third-party oversight, and discuss strategies to address these emerging issues in future trials.

  • Review key takeaways from the FDA Draft Guidance on Decentralized Clinical Trials
  • Examine the oversight challenges investigators face when working with third-party vendors, including home health agencies
  • Identify practical strategies to strengthen oversight and address gaps in decentralized and hybrid trial models
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While clinical trials often focus on start-up, recruitment, and data collection, planning for what happens after a trial ends is becoming an essential ethical and regulatory priority. Sponsors, CROs, and sites must consider how participants may continue accessing investigational products when appropriate and ensure clear expectations are built into trial planning and documentation. How can sponsors, CROs, and research sites proactively design post-trial access strategies?

  • Understand regulatory and ethical expectations around post-trial access to investigational products
  • Identify gaps in protocols, CTAs, and informed consent forms
  • Explore strategies for budgeting, contracting, and transition planning to support responsible post-trial access
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Artificial intelligence is rapidly transforming healthcare, with nearly two out of three physicians now using AI-enabled tools. While these technologies offer significant opportunities to improve care and efficiency, they also raise important concerns around patient safety, data integrity, and bias. If AI models are not properly trained or monitored, they can unintentionally introduce disparities or compromise clinical decision-making. As AI systems become more advanced and autonomous, how do you ensure they stay fair and non-biased?

  • Examine the importance of algorithm transparency and data use rights
  • Assess potential risks AI poses to patient safety and data integrity
  • Strategize ways to ensure AI adoption aligns with ethical, legal, and regulatory standards
Speaker:

The U.S. Department of Justice Final Rule, effective April 8, 2025, introduces new restrictions on transferring sensitive data to 'countries of concern' or to individuals and organizations associated with them, including vendors and contractors. These restrictions significantly impact the sharing of bulk sensitive data, particularly in areas such as human genomic data, biometric identifiers, and personal health information. How can teams ensure compliance while maintaining efficient global collaboration?

  • Review the key provisions and implications of the DOJ Final Rule
  • Understand exemptions and permitted pathways for sensitive data sharing
  • Examine real-world scenarios and case studies for applying the rule in practice
  • Assess emerging cybersecurity risks related to global data transfers
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The Protocol Simplification Championship (PSC) is a structured, incentive-based framework designed to reduce clinical protocol complexity. PSC applies principles of healthy competition, cross-functional collaboration, and recognition to motivate teams to identify and implement practical simplification opportunities. Through a transparent evaluation framework and peer recognition, the initiative shifts protocol simplification from an aspirational goal to an engaged, measurable activity.

  • Describe the PSC model, implementation considerations, and key lessons learned
  • Go over a practical approach to embed protocol simplification into clinical development to improve study execution and operational efficiency
Speaker:

Fair Market Value is a cornerstone of clinical trial operations, yet determining appropriate investigator compensation remains one of the most complex and debated aspects of trial budgeting. Sponsors, CROs, and sites must balance regulatory compliance with realistic compensation for investigator time, site resources, and operational demands. As costs rise and trial complexity increases, organizations must rethink how FMV is determined and applied to ensure budgets support both compliance and sustainable site partnerships.

  • Understand how FMV aligns with regulatory frameworks governing healthcare payments
  • Examine the balance between fiscal discipline and building long-term site partnerships
  • Go over key FMV components, including indirect costs, inflation adjustments, and pass-through expenses
Speaker:

The informed consent process is a foundational requirement for protecting human subjects in clinical research and is a critical component reviewed by Institutional Review Boards. However, many organizations struggle with creating consent documents that both meet regulatory requirements and remain understandable for patients. What are the best practices for creating compliant, patient-centered informed consent forms and improving the overall consent process?

  • Improve readability and patient comprehension of consent documents
  • Align consent language with protocol procedures and study risks
  • Understand the required regulatory elements of an informed consent form
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Day 1 Concludes

Regulatory inspections and clinical trial audits don't begin when inspectors arrive, they start months earlier through the daily monitoring, documentation, and oversight practices implemented by study teams. As trials become more complex and increasingly supported by digital tools, organizations must build inspection readiness into their routine clinical operations. How can teams proactively prepare for audits and inspections while leveraging digital workflows?

  • Understand what true inspection readiness looks like in modern clinical trials
  • Strengthen monitoring strategies and documentation practices to support GCP compliance
  • Improve site oversight and CRA monitoring processes to detect issues early
Speaker:

Tax compliance has long created challenges for sites, sponsors, CROs, and trial participants. The 'One Big Beautiful Bill' raises the 1099 reporting threshold for clinical trial stipends from $600 to $2,000, effective January 1, 2026, with future adjustments for inflation. This change may reduce administrative burden for sites while making it easier for lower-income patients to participate in clinical trials. While this is an important step forward, additional changes may still be needed to fully address participant payment and reimbursement challenges across the clinical research landscape.

  • Examine what the new legislation means for sites, sponsors, CROs, and trial participants
  • Rethink participant compensation models to support equitable trial participation
  • Navigate global approaches to participant payments and best practices for site reimbursement
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In order to achieve successful partnerships and expedite negotiation timelines, it is crucial to establish strong, collaborative relationships among sponsors, CROs, and sites. Poor communication can result in extended negotiation periods, increased misunderstandings, and unnecessary frustration. How can your team foster an environment that encourages open and transparent communication for all parties involved?

  • Examine how each sponsor, site, and CRO can play a role in fostering clearer communication
  • Enhance the communication process to achieve efficiency
  • Recognize the benefits of having clear and concise communication language
Speakers:

The publication of ICH E6(R3) in September 2025 reflects the growing complexity of modern clinical trials and introduces updated expectations for sponsor oversight. The guideline reinforces that sponsors remain ultimately responsible for trial quality, patient safety, and data integrity, even when multiple vendors and service providers are involved. As clinical trials rely on increasingly complex vendor ecosystems, organizations must rethink how they evaluate, manage, and oversee partners to remain compliant with the updated guidance.

  • Review the key principles and structural updates introduced in ICH E6(R3)
  • Embed Quality by Design into protocol development and trial planning
  • Develop strategies for effectively managing multi-vendor ecosystems and oversight responsibilities
Speaker:

Clinical trial site budgeting has become significantly more complex as the industry faces rising inflation and shrinking budgets. Rising operational costs, supply chain disruptions, and staffing shortages are placing unprecedented financial pressure on research sites and reshaping how sponsors negotiate clinical trial budgets. How can we support workforce sustainability and strengthen site partnership in uncertain times like these?

  • Understand how inflation and workforce shortages are impacting clinical trial site costs
  • Go over how to integrate technology to drive patient recruitment
  • Improve collaboration between sponsors, CROs, and sites during budget discussions
Speaker:

Sponsors are facing a site-level infrastructure crisis driven by Private Equity (PE) consolidation and unvetted AI. Traditional agreements often fail to bridge the gap between investment-heavy ownership and clinical execution. This session analyzes emerging litigation trends to help sponsors fortify their legal footprint against negligent drafting and structural gaps.

  • Address Inappropriate Party Contracts
  • Mitigate AI-Related IP Leakage
  • Reduce Sponsor Liability in Site Disputes
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Data is one of the most critical and valuable assets collected and created in a clinical trial. Sponsors and sites frequently argue over data rights, data terms in CTAs, data protection and privacy language in ICFs, and permissible use cases. In addition, informed consent forms often miss key opportunities to allow for broader use cases, where legally permissible, or make affirmative statements around data that are unnecessarily limiting or introduce potential risk to sponsors and sites.

  • Understand the guardrails and requirements around data use and data rights in clinical trials
  • Identify key risks and ways to mitigate them, particularly through language in the ICF
  • Enhance data rights while ensuring participant data is protected and participants are adequately informed about uses of their data
Speaker:

By 2026, over 70% of CROs are expected to deploy AI-driven analytics to streamline protocol design and accelerate study execution. However, CROs continue to be one of the biggest bottlenecks in study start-ups, prolonging negotiations between the site and the sponsor while working within a small start-up timeframe. Because of this, changes need to be made to ensure sponsors, sites, and CROs are all hitting their milestones. What are some strategies needed to accelerate study start-ups?

  • Examine the CRO's role and responsibilities in the negotiation process
  • Brainstorm communication strategies that improve alignment between sponsors, sites, and CROs
  • Highlight the value CROs bring to clinical trial execution and opportunities to optimize collaboration
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