Conference Schedule

Study milestones are a core component of every clinical trial contract, designed to keep the trial moving forward efficiently and on schedule. Yet in practice, these milestones are often delayed—leading to prolonged timelines, operational bottlenecks, and mounting frustration across stakeholders. So, how can you ensure your team stays aligned and accountable?

  • Examine ways to properly manage study milestones
  • Tackle challenges that usually push back milestones
  • Communicate efficiently to ensure you are set up for success
Speakers:

A successful clinical trial generates vast amounts of data, but how much of it truly needs to be captured? What level of detail does this data need to encompass? Finally, how can you efficiently capture data while ensuring its security and privacy?

  • Look at how different companies capture data in their studies
  • Determine what level of detailed data needs to be reported
  • Ensure data privacy and quality during the study
Speaker:

Trial activation delays remain one of the most persistent challenges across clinical research. In this session, discover how to accelerate study start-up by implementing a dynamic study activation dashboard—an early warning system that transforms reactive tracking into proactive management. By integrating measurable KPIs, service line agreements, and automated insights, this approach empowers faster, more aligned activation timelines.

  • Explore what data is essential to build such a tool, and how to identify the right stakeholders for meaningful impact
  • Understand how to design a real-time study activation dashboard that aligns crossfunctional teams and reports early warning signs of delay
  • Identify the measurable KPIs, task timelines, and stakeholder communication strategies that ensure faster timelines
  • Learn how to collect and present key data to stakeholders to ensure intentional prioritization
Speaker:

When building a contract for your study, it is imperative that you know what to look for and how to negotiate your needs. CenterWatch, a WCG Company, states that the number of days sites spend negotiating budgets has risen by 62% in the past two years. Based on these statistics, your team should learn how to streamline the process and plan for the future.

  • Examine financial issues when negotiating a contract
  • Reflect on common contracting delays and how to avoid them
  • Highlight the key lessons of a streamlined, low-stress contracting process
Speaker:

Medical Science Liaisons are vital to the success of Investigator-Initiated Trials, serving as the bridge between investigators and sponsors. Their ability to effectively communicate investigator insights and foster collaboration is key to initiating and advancing IITs. How can you ensure that the MSL, investigator, and sponsor all cultivate a healthy, transparent, and productive working relationship?

  • Hash out ways that MSLs choose suitable investigators and the challenges they face through those interactions
  • Define roles and responsibilities to ensure smooth collaboration
  • Address common barriers to collaboration
Speakers:

Investigator-Initiated Trials are uniquely positioned to explore areas traditional industry sponsored trials may overlook. From addressing unanswered clinical questions to refining treatment approaches in real-world settings, IITs can generate evidence that directly informs clinical practice and improves patient care.

  • Identify and prioritize research that addresses unmet clinical needs
  • Design trials that reflect real-world patient populations
Speaker:

Using imaging biomarkers can accelerate clinical development and reduce risks to both sponsors, investigators and research subjects. In what ways can your team use these biomarkers to streamline IITs?

  • Go over the advantages of using noninvasive biodistribution studies instead of toxicology studies
  • Specify in the contract that in cases of ambiguity or discordance, the investigator's SOP and understanding takes precedence
  • Explore strategies to align faster decision-making with ethical, patient-centered research
Speaker:

Day 1 Concludes

Running a successful study hinges on effective, ongoing communication between the investigator and sponsor, and that communication starts with choosing the right partner.When collaboration breaks down or communication is inconsistent, it can lead to delays, misunderstandings, and missed study milestones. Are you selecting study partners who can communicate clearly and contribute to the success of your trial?

  • Grasp the importance of communication, especially early in a study
  • Brainstorm ways to improve your communication tactics
  • Train teams on active listening, empathy, and clear messaging techniques
Speakers:

With a new administration in the White House, the FDA is implementing shifts that are influencing clinical trial design and conduct in multiple ways. Staying ahead of these evolving regulations is critical to ensure compliance and trial success. Are you prepared to navigate these changes? What strategies can you use to stay informed and adapt quickly in this dynamic environment?

  • Discuss what these changes mean for sites and sponsors
  • Study informed consent, digital technologies, and the diversity action plan
  • Debate what the future of IITs looks like in 2030
Speaker:

Getting a study off the ground quickly is a challenge every team faces.Study start-up is often where the most delays occur, from slow contracting and regulatory submissions to investigator onboarding and site readiness.Clinical Researcher, Robert Dannfeld, writes that 80%of studies do not reach their recruitment targets.As expectations for faster execution increase, how can you build a more efficient process?

  • Identify the most common causes of start-up delays
  • Explore tools and technology that accelerate contracting
Speakers:

Collaborative studies and IITs differ in structure, control, and oversight. Collaborative studies don’t have as many regulations surrounding them. This leads to the question, how can you determine whether a study is collaborative, or investigator initiated? Also, how can you handle the extra challenges that come along with collaborative research?

  • Explain the difference between a collaborative and investigator-initiated trials
  • Walk through how to handle trials that are very unregulated
  • Consider the data ownership challenges that arise from collaborative research
Speakers:

Assessing Fair Market Value has long been a complex challenge, influenced by geography, institutional policies, and therapeutic area. Yet, FMV remains a critical benchmark—ensuring funding requests are both reflective of the true cost and value of the proposed research. In 2025, the integration of technology in clinical trials has accelerated, helping streamline operations and reduce timelines. Innovative digital tools and platforms are now being leveraged to assess FMV with greater accuracy and efficiency.Can your team harness this technology to help assess FMV?

  • Uncover the importance of Fair Market Value
  • Review key factors that influence FMV, including geography, study type, and market trends
  • Explore how emerging technologies are transforming FMV assessment
Speaker:

Establishing strong relationships between clinicians, scientists, and industry partners is essential for driving innovation in academic medical centers. However, challenges such as limited resources, budget constraints, and the absence of clinical partners can hinder study execution and patient enrollment. Can your team build practical strategies to bridge these gaps and foster productive partnerships that accelerate scientific discovery in real time, rapidly and accurately?

  • Understand how to strengthen partnerships between academic medical centers and industry partners to enhance study impact
  • Grow a relationship between clinicians, scientists, and academic medical centers
  • Strategize ways to increase patient enrollment in a clinical study
Speaker:

How can resource-limited investigators leverage data-driven insights and community-informed strategies to improve clinical trial efficiency and inclusivity? Drawing from CISCRP’s Journey to Better Health (JTBH) mobile exhibit, Perceptions & Insights (P&I) Study, and educational material, attendees will gain practical guidance on aligning study design and outreach with public and patient preferences. The session will highlight scalable, community-centered approaches to recruitment, communication, and trust-building that can be implemented even with constrained budgets.

Speaker:

Academic medical centers often have administrative offices that can provide resources and expertise to help meet enrollment goals. The development of an honest broker model has been shown to be particularly effective across a variety of studies.

  • Discover how to identify institutional resources
  • Review questions to ask when developing your protocol
  • Understand the process of developing a HB model
Speaker:

Conference Concludes

 

 

 

 

 

 

 

I Accept