Archives: Agenda

When innovation doesn’t go as expected

  • A case study from WinSanTor
  • How to best implement innovative e-clinical software systems to ensure they work within the service provider universe
  • A harmonious partnership: Balancing innovation and data safety
  • When service providers have too much power, how can we ensure innovation isn’t stifled?

PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight

  • Accomplishing the right vendor selection to ensure better equipped budget and overhead wise for smaller companies
  • Optimizing boutique service providers to guarantee the flexibility and attention you need for study start up
  • Building the appropriate infrastructure needed to scale up clinical research and knowing when to invest in outsourcing services
  • Looking at the latest technologies which are demonstrating that scalability is a solvable problem
  • Having a comprehensive understanding of global requirements and timelines

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

FIRESIDE CHAT: Reinforcing the sponsor’s pivotal role in ensuring trial integrity with the latest ICH E6 (R3) updates on sponsor oversight

  • What are the guidelines suggesting sponsors to do internally, from the perspective of QA, governance and metrics?
  • Recommended vendor management reporting: the oversight, the eTMF and data quality/ validation oversight
  • How are sponsors going to address these suggested new guidelines from ICH and what are the timelines to react and the most immediate need?
  • Understanding updated requirements to document oversight of who is contracted with any sub-contractors
  • Focusing on a proportionate risk-based approach to vendor oversight and encompassing a broad range of information
  • Addressing the robustness of the Quality Management System or oversight of vendors and highlighting the data types that the ICH suggests
  • Processes and practices currently being implemented that are responding well to the ICH guidelines

Moderator: Melody Puckett, Director, GXP Quality, Janux Therapeutics

 

 

KEYNOTE: Leveraging data-driven insights and cross-functional collaboration to drive innovation in clinical trials

  • Placing data-driven insights at the core: Need for integrating real-world data (RWD) and real-world evidence (RWE) into clinical trial design
  • How data-driven insights enhance patient engagement and improve trial outcomes, addressing unmet patient needs?
  • Driving patient-centric innovation with AI: Role of AI in personalizing patient selection, optimizing recruitment, and predicting treatment responses
  • Bridging silos: medical, commercial, and clinical teams: Impact of collaboration between commercial, medical, and clinical teams to ensure a holistic patient journey
  • Harnessing technology for improved trial efficiency: Examples of successful deployments of AI and analytics in clinical trials, showing measurable impacts on trial success rates

Studies Beyond Borders: Managing the logistics of conducting worldwide clinical trials

  • Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
  • Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
  • Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
  • Addressing concerns at the protocol and ICF development phase

Flawed data from inadequate oversight: Everyone’s problem and no one’s problem

  • Protocol deviations – missed or swapped samples, mistimed dosing, skipped assessments – quietly compromise trial integrity
  • Errors are identified too late with current approaches to clinical trial conduct
  • Real-time oversight enables faster, cleaner data through stronger protocol compliance and earlier course correction
  • Proactive and risk-based quality management under ICH E6(R3) provides earlier visibility into site execution
  • Real-world examples of preventable deviations that delayed trials and jeopardized data

Executing innovative data collection and monitoring strategies to capture high quality patient experience data (PED)

  • What is PED and how is it influencing clinical research today
  • It all begins with smart science – A strong scientific foundation paves the way for creation of fit for purpose PED strategies.
  • Technology is key – Leveraging eCOA and Digital Health Technologies to capture PED
  • Data oversight is essential – Using real-time PED monitoring strategies to protect study endpoints
  • Keeping it real – We will explore real life examples of how robust PED strategies are used in the context of Obesity & Oncology research