Archives: Agenda

Transforming Sponsor-CRO Partnerships for Clinical Trial Success: Innovation, Transparency and Agility

This session will delve into innovative approaches to sponsorCRO partnerships, with a focus on building stronger stakeholder relationships, enhancing transparency, and managing teams effectively.

• Identify innovative processes and partnership strategies to elevate sponsor-CRO collaborations.

• Understand the role of transparency and centralised data in fostering trust and alignment.

• Learn how AGILE team management can improve efficiency and responsiveness in clinical trials.

• Gain insights from a case study of a successful sponsor-CRO partnership.

Patient Centricity in Clinical Development; what & how?

·       Exploring the principles and practices of patient-centric approaches in clinical trials

·       Discussing practical applications to enhance trial design, execution, and outcomes

·       Introducing EUPATI: Empowering patient involvement through education

 

Smoothing the Patient Journey and Driving Trial Efficiency with eClinical Innovations

This session will explore the patient experience within clinical trials, and how eClinical solutions can be an essential strategy for easing patient and site burdens.

In this session, we will explore:

  • Why do patients participate in clinical trials? The statistics might surprise you.
  • The challenges patients experience during their trial journey.
  • What the recent updates to the Declaration of Helsinki mean for patient centricity.
  • How to make it easier for patients and sites to participate in trials.
  • Approaches and technological innovations that improve the trial journey and drive efficiency.

A Fit-for-Purpose Framework for Effective Technology Strategies in Clinical Trials

Discover a 5-step framework to define, design, cross-check, measure, and analyze the right technology and operational execution for your clinical trials. This session highlights the eConsent Fit-for-Purpose Study Framework, developed by the non-profit European Forum GCP eConsent initiative in collaboration with over 50 organizations. Additionally, we will explore the importance of harmonized terminologies, study documents requirements, and insights into Ethics Committees’ expectations for eConsent. While focused on eConsent, this approach can be re-used for developing similar frameworks tailored to any technology or Decentralized Clinical Trial Element

Addressing the challenge of digital adoption in clinical trials

Case Study: streamlining the implementation of multiple solutions

 

·       Making a case for digitization – a Sponsors perspective

·       Implementation, planning and design considerations

·       Establishing standards and SMEs

·       Refining and looking to the future

Panel Discussion Unravelling the Impact of ICH E6 Revision 3: Implementing New Standards in Good Clinical Practice

ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

  • Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct.
  • Explore different approaches to implementing the new guidelines in diverse trial settings.
  • Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3).
  • Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts.

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?

 

Panel Discussion Embracing Innovative Technologies in Clinical Trials: Opportunities and Challenge

Exploring how new technologies are transforming clinical trial processes, improving efficiency, and addressing challenges. The session will focus on real-world applications, benefits, potential risks, and future implications.

  • Why, historically is Pharma so slow to adopt new technologies? Averaging up to 7 years according to a 2022 Tufts Study
  • Current Innovations in Clinical Trials; How technologies like General AI and Large Language Models, prognostic and predictive deep learning, and direct data transfer (or EHR to EDC) are enhancing trial efficiency and patient outcomes.
  • Overcoming Challenges; Regulatory hurdles: How are agencies responding to new technologies?
  • Ethical considerations: Ensuring patient data privacy and compliance.
  • Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
  • Future Outlook: What technologies will dominate in the next 5–10 years? (perhaps 7-14 years considering the tech adoption cycle)
  • How can stakeholders (pharma, CROs, tech companies, regulators) collaborate effectively??

 

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.