Conference Schedule

Speaker:

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:

In 2023, the US Department of Health and Human Services proposed updates to revise the Public Health Service Policies on Research Misconduct, addressing critical issues such as confidentiality clauses, site audit rights, data integrity, and financial implications. These changes may necessitate revisions to current CTAs. How can your company effectively navigate these updates?

  • Identify the challenges associated with the new proposed changes
  • Examine how sites and sponsors are impacted
Speaker:

Reducing clinical trial activation timelines is a key priority for many in the industry. How long does it take for your study to open for enrollment? Achieving faster activation requires strategic management of contracts, budgeting, and operational workflows. Be prepared to explore common bottlenecks in study start-up, share best practices for optimizing key processes, and provide actionable insights to help your team accelerate trial activation.

  • Identify the most common delays within activation timelines
  • Explore strategies to streamline contract and budgeting processes
  • Brainstorm ways to implement this process in your own organization
Speakers:

Outsourcing CTAs is typically managed through CROs and vendors. However, have you considered leveraging CTA attorneys to support this process? They bring valuable expertise in budget development, informed consent forms, patient recruitment, data integrity, intellectual property rights, and more. How does collaborating with CROs differ from working with attorneys?

  • Discuss the responsibilities that attorneys and CROs deal with in the negotiation process
  • Weigh the pros and cons of working with each
Speaker:

According to GlobeNewswire, the decentralized clinical trial market is projected to reach $16.29 billion by 2027, highlighting the growing importance of incorporating decentralized and hybrid methods into clinical trials. However, challenges remain when it comes to agreeing on remotely monitoring studies for sites. Issues such as indemnification clauses, time management, PI responsibility, and other factors can complicate the adoption of these methods. How can your team overcome these obstacles to effectively implement remote monitoring in clinical trials?

  • Go over the challenges associated with remote monitoring from a site and sponsor side
  • Determine how much responsibility should fall on the site PI when conducting monitoring visits
Speaker:

As we are entering into a time where many smaller biotech companies are merging with larger companies, there are questions surrounding how CTAs will be affected. How should your team react during this transition period?

  • Learn what is important to include in a CTA in preparation for a company merge
  • Map out how smaller biotech companies can prepare themselves for a transition
  • Understand the intricate details that go into a company merger
Speaker:

International agreements introduce a complex set of regulations and requirements. In addition to navigating diverse regulatory landscapes, teams must also consider cultural norms, data privacy laws, language barriers, and varying legal jurisdictions. How can your team successfully navigate these challenges and excel in completing a global CTA?

  • Explore each set of global differences and brainstorm solutions to solve them
  • Spotlight China and Europe when discussing these differences
Speakers:

Choosing the right CRO is a critical step in ensuring the success of your trial. The right partner can enhance cost-efficiency, streamline processes, and proactively identify potential challenges before they occur. How can your team effectively evaluate and select the CRO or vendor that best aligns with your needs?

  • Review the importance of CROs and what they contribute to the clinical trial process
  • Clarify what goes into selecting the correct partner
  • Distinguish the key factors in selecting a CRO for a large pharma company versus a small pharma company
Speakers:

A well-structured CTA is essential for ensuring sites can successfully execute studies while maintaining financial and operational efficiency. Budget negotiations should be transparent, accurately reflecting study costs for all parties. Clear payment terms and well-defined contract provisions are key to fostering collaboration between sponsors and sites. Additionally, providing comprehensive study details at the budget assessment stage enhances site readiness and overall trial execution. Can your team navigate the intricacies of ensuring a well-structured CTA?

  • Go over essential elements of budget assessment
  • Leverage accurate templates and differentiate key study components to expedite time to execution
  • Navigate contract negotiation as a collaborative process
  • Define reasonable payment terms and contract clauses to support study success
Speaker:

Day 1 Concludes

Speaker:

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
  • Explore 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:

Budget negotiations are a major factor in delaying study start-up timelines. Sponsors and sites must find common ground on budget expectations. PwC's Health Research Institute predicts a 7% rise in healthcare costs in 2024. As trial costs continue to rise, sponsors face increasing pressure to justify expenses, while sites struggle to keep pace with inflation. How can sponsors and sites bridge this gap and reach mutually beneficial agreements?

  • Examine common site fees and how inflation is impacting these negotiations
  • Discover ways for sites and sponsors to improve their negotiation timelines
  • Investigate how fair market value contributes to this
Speaker:

Understanding fair market value can be challenging due to its dynamic nature and the fact that it varies by site location. How is FMV accurately determined, and what factors are considered in the data collection process? How can your team ensure fair and consistent FMV assessments across different sites?

  • Evaluate how FMV can affect clinical trial budget negotiation
  • Review how to include site rate cards and standardized pricing
  • Debate the importance of FMV between sites and sponsors
Speakers:

In 2025, significant regulatory changes are reshaping the clinical trial landscape. However, the full impact of these changes remains uncertain as the industry navigates this evolving environment. How will the new legislation influence diversity guidance, global regulatory variations, trial designs, Medicaid implications, and other critical areas in the future?

  • Analyze the importance of understanding the current legislative landscape
  • Highlight any new regulatory changes and how they are affecting trials
  • Predict what the regulatory future will look like
Speakers:

Mergers and asset acquisitions introduce complexities in site contracting, requiring a strategic approach to managing templates, executed agreements, and transitions between Sponsor or CRO-partnered contracts. Understanding cross-functional relationships, particularly with payments, is critical for minimizing disruptions. Does your team understand how to mitigate these challenges?

  • Identify common challenges in site contracting
  • Explore strategies for streamlining contract management
  • Examine the role of cross-functional collaboration
Speaker:

Accelerated clinical trial agreements can expedite the contract negotiation process. However, they have received some push-back due to legal risk exposure, indemnification obligations, and more. Even though there are some drawbacks, how can ACTAs impact the clinical trial landscape?

  • Reflect on prior successes and failures
  • Map out which clinical trials this process could benefit
  • Discover how implementing a standard template in ACTAs could be beneficial to the sponsor and the site
Speakers:

In clinical trial agreements, one of the most critical considerations is determining who owns the intellectual property. Since this is a highly important matter, it often requires case-by-case negotiation. What factors influence the decision when negotiating IP ownership in a contract? How can your team ensure a fair and clear agreement on this crucial aspect?

  • Clarify the importance of IP rights
  • Decide who obtains those rights when there is more than one sponsor in the study
  • Uncover the challenges with IP rights when dealing with an IIT
Speaker:

Determining responsibility for subject injury is a critical aspect of CTA negotiations. How will the costs associated with injuries be covered, and who will bear the financial responsibility? While some cases may seem straightforward, others can be complex and require careful consideration when assigning liability. How would your team approach and resolve specific cases of subject injury, ensuring clear and fair agreements for all parties involved?

  • Observe examples of subject injury cases and determine how to handle each case
  • Look at different subject injury common language examples
  • Determine the responsibilities of the sponsor and the site
Speakers:

Conference Concludes

 

 

 

 

 

 

 

I Accept