Archives: Agenda

From setback to success: The art of clinical trial rescue

In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel’s extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

 

·       Strategic Initiation & Planning – establishing a robust framework and standardized processes

·       Comprehensive Preparation & Due Diligence – ensuring stakeholder alignment on transition plans and timelines – Conducting thorough documentation review and gap analysis

·       Adaptive Execution & Transfer – How to operationalize a study transfer – Anticipating challenges and employing agile governance for real-time course corrections

·       Effective Closure & Delivery – defining clear transition thresholds and success metrics  – Ensuring continuity and maintaining data integrity throughout the process

PANEL Sharing experience & Lesson Learned with EU CTR for clinical trial approval

 

·       How is the European region ranked in competition to North America, Latin America, and APAC for being selected to conduct clinical trials – since EU CTR in place?

·       How best to avoid delays in study approval in Europe compared to other regions in global trials?

·       Experience & Lesson Learned with patient recruitment material & eCONSENT in EU study approval since EU CTR is in place?

 

Strategic Site Selection: Identifying the Right Sites, People, and Advocates for Trial Success

Selecting the right sites and investigators is critical for successful clinical trials, especially in multidisciplinary studies. This session will explore strategies for targeting sites that align with study goals, investing in investigators who not only have the skills but also believe in the product, and leveraging key opinion leaders (KOLs) who can enhance the trial’s impact. We’ll cover key factors in recruitment, including site capability, investigator influence, and alignment with product objectives.

  • Learn strategies for identifying and selecting sites that align with trial needs and patient demographics.
  • Understand the importance of choosing investigators who are both competent and product advocates.
  • Explore the role of KOLs in influencing trial outcomes and enhancing product credibility.
  • • Discover best practices for collaborating with the study startup team to ensure smooth trial initiation.

The Data Advantage: Integrating RWD, Historic Clinical Data, and AI for Regulatory Success and Better Patient Outcomes

The success of clinical trials depends on selecting the correct data to answer critical questions: How can we optimize protocol design? Which patients are the best fit? What real-world impact will our treatment have? This session provides a strategic framework for leveraging historical and real-time clinical trial data, real-world data (RWD), and synthetic data—ensuring that every research decision is guided by the most relevant, high-quality evidence to drive efficiency, accuracy, regulatory success, and the best long-term patient outcomes.

What the audience will gain from your presentation:

 

·       Data Selection Framework: Determining which type of data—historical clinical trial data, cross-industry operational data, RWD, or synthetic data—best answers specific clinical research questions.

·       Risk vs. Reward: Understanding the trade-offs of each data type, including data quality, generalizability, and potential biases.

·       Regulatory & Scientific Considerations: How different data types align with regulatory expectations and scientific rigor.

·       Real-World Applications: Case studies illustrating how the right data choices have led to better trial outcomes and faster regulatory approvals.

 

AI in trial master file management: The good, the bad, and real-world use cases.

·       Use Cases: How AI has already improved efficiency and compliance in TMF operations with numbers and KPIs we all love

·       The Pitfalls and Limitations: Where AI still falls short

·       Human + AI = Better TMF: Why the most effective setups are hybrid — combining AI speed with human oversight

·       What’s Next? A look into emerging trends and how sponsors and CROs can start preparing for AI-enabled TMF strategies

 

Cybersecurity in Vendor Qualification

This session will highlight the importance of cybersecurity in vendor qualification, discussing current challenges, and provide practical strategies to safeguard clinical trial data and processes.

Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

 

  • Building a Global Regulatory Strategy: Insights, Pitfalls, and Lessons Learned
  • Setting the Standard: Best Practices for Successful Regulatory Submissions
  • Fast-Tracking Innovation: Accelerating Regulatory Pathways in Special Contexts
  • Understanding Delays: Challenges in the Evaluation of High-Risk Clinical Trials
  • Patient-Centric Strategy in Regulatory Submissions: The Role of Sponsors and Regulators

Rethinking Clinical Operations: A Smarter, Faster Playbook for Trial Success

The CRO-Sponsor model is broken. This session will explore a fresh approach to clinical trial outsourcing, addressing inefficiencies in the traditional CRO-Sponsor model. Learn how to enhance collaboration, improve trial execution, and accelerate timelines with a results-driven framework.

 

•         Discover a smarter outsourcing model that boosts agility, transparency, and accountability.

•         Learn how the “High-Retention” Trial Strategy—powered by AI-driven recruitment and patient engagement—helps achieve enrolment targets faster.

•         Explore real-world case studies showcasing optimized trial execution across high-risk indications.

•         Gain insights into the biggest shifts shaping clinical operations over the next five years—and how to stay ahead