Decentralized & Hybrid Clinical Trials 2025 Europe

Patient-centric approach to Decentralized & Hybrid Trials: Understanding the changing landscape, the trends, challenges, and opportunities for a successful implementation.

Copthorne Tara Hotel London Kensington, London, United Kingdom
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Co-located with the 7th Patient Centricity & Collaboration World Congress 2025 Europe 

Decentralized & Hybrid Clinical Trials World Congress 2025 Europe

Dear Colleagues,

Facilitate Live is very pleased to welcome you to our upcoming Decentralized & Hybrid Clinical Trials World Congress 2025 Europe.

Decentralized clinical trials (DCTs) are clinical trials that take place outside of traditional clinical trial sites. They can include activities at a participant’s home, a local health care facility, or a nearby laboratory versus requiring the patient to come to the major clinical facility of the lead researcher. This is made possible through virtual collaboration between the lead researcher and local medical teams, enabled by technology such as apps, electronic monitoring devices, telemedicine and video consultations, and facilitated and monitored through home visits. In addition, researchers can recruit participants from diverse backgrounds and obtain real-world data more quickly and cost-effectively.

A decentralized or virtual protocol is a growing innovation in the conduct of clinical trials. DCTs allow patients to choose how and where they take part in the study, which can be especially beneficial for patients with rare diseases or reduced mobility. Other benefits of DCTs includes less friction in accessing healthcare, more potential for health equity and inclusion in clinical trials, improved patient recruitment and retention, greater potential for the conduct of trials in low prevalence diseases, shorter study timelines, accelerated delivery of new treatments, and improved data quality and accuracy, and ultimately, lower healthcare costs to society.

However, Decentralized clinical trials (DCTs) have several potential issues. DCT designs need to consider how much data to collect and how to store and process it. Data quality may be compromised due to the diverse technologies being used which may introduce variability in data quality. There’s a higher risk that patients could use a device incorrectly or record data incorrectly. Researchers should make the process for study consent and withdrawal as user- friendly as possible. The need for vigorous data security and privacy solutions to safeguard sensitive information. Managing participant safety is a factor that trial leaders must also address. There is the risk of technological failure, which could lead to a loss of patient data. DCTs need to comply with regulations. Another issue with DCTs is, some patients may be more comfortable being seen in person, especially if they are unsure about using technology or administering tests.

The upcoming Decentralized & Hybrid Clinical Trials World Congress Europe aims to bring together stakeholders to discuss strategies and best practices, innovations, technologies and concepts that addresses the issues surrounding DCTs, in a dynamic interactive, thought-provoking and uplifting manner.

We look forward to welcoming you to the Decentralized & Hybrid Clinical Trials World Congress 2025 Europe  

Sincerely yours,

Jocelyn Raguindin
Conference Director
Facilitate Live

GAIN LATEST INSIGHTS ON:

WHO SHOULD ATTEND?

This Congress will provide information to pharmaceutical and biotech companies, researchers, physicians, institutional review boards (IRBs), patient organizations and advocates, and regulatory agencies about the implementation of Decentralized Clinical Trials.

Network with members of the boards, VP’s, Directors, Heads/Chiefs, and Senior Managers of leading Pharmaceuticals and Biotech Companies, Government, CRO’s and Solution Providers Involved in:

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Key Industry Expert Speakers

Mohamed Sharaf

EMEA Regional Senior Medical Advisor

Johnson & Johnson

Saryu Goel

Senior Pharmacology/Toxicology Reviewer

FDA

Angela May

Strategic & Operational Leadership | Stakeholder Engagement

DCT Advisor

Rasmus Hjorth

Head of Communication

James Lind Care

Prof. Dr. Volodymyr Anisimov

Data Science Associate Director, Center for Design & Analysis

Amgen

Diane Driver

Head Program Delivery, GCSO

UCB

CAROLE SCRAFTON

CEO & Co-Founder Patient Advocacy Organisation

FibroFlutters

Van Zyl Engelbrecht

Head of Country Operations / Decentralised Clinical Trials & Innovation / Rare Diseases / Regulatory Affairs

Alexion Pharmaceuticals, Inc

Dr Catherine Blewett

Senior Development Manager

Health Research Authority (HRA)

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Schedule

Content Rich Program Agenda!  Featuring Keynote Presentations, Stream Sessions, Panel, and Round Table Discussions.

REGULATORY GUIDELINES

  • Addressing varying regulatory guidelines for DCT
  • Emerging regulatory frameworks and approaches
  • Potential opportunities and challenges for DCT solution providers.
  • Regulations clarifying access to health technologies and technical requirements.
  • Adhering with data privacy laws and compliance
  • Lessons learned and future of DCTs

Moderator:

Panelist:

  • Brief overview of the current guidelines
  • ACT EU Pilot scheme for trials with decentralized elements
  • Harmonised and transparent approach for the use of DCT elements in clinical trials.
  • Review outlines of gap analysis focused on the frameworks and guidance
  • The need for a comprehensive sustainability assessment of each DCT element
  • Guidance related to a comprehensive assessment of designing and executing sustainable DCTs needed
  • Factors stakeholders regard as having the most significant impact on driving sustainability decisions in DCTs.

CURRENT TRENDS AND STRATEGIES

  • Current role of digital platforms in supporting decentralized trial activities
  • Challenges and benefits of digital platforms to investigators and participants
  • The obstacles developers must address before a fully integrated and unified DCT can be realized.
  • New tools and framework that facilitates progressive decentralization
  • Technological developments in telehealth
  • Important aspects to consider when conceptualizing a phase 1 decentralized clinical trial
  • Examples of promising model for early drug development.
  • Current adoption of remote monitoring and data collection technologies
  • Drivers of increasing adoption of remote monitoring and data collection technologies
  • Remote monitoring and data collection technologies with greatest outcomes associated with patient experience
  • Aspirations and direction for industry to enable more patient-centric trials.
  • Ethical aspects of digitalization in clinical trials associated with digital technologies
  • Informed consent in clinical research
  • Decentralized informed consent procedures that are impacted by digitalization
  • Electronic consenting technologies and procedures
  • Opportunities and Considerations
  • Data-Driven Solutions in Planning and Feasibility of Clinical Trials
  • Various decentralization components available for stakeholders to increase the reach and pace of their trials
  • Fit-for-Purpose, Usability Studies, and Contingencies
  • Examples of trials with dual DCT and DHT components
  • What is IRT and why use it for your trial?
  • Greatest challenges and obstacles to consider when selecting new IRT innovations?
  • Technical and operational considerations in selecting an IRT vendor
  • What are the benefits to look for?
  • Perspectives and guidance for effective eCOA in global DCTs
  • Preparations to implement eCOA in your global DCTs
  • What are the complexities of the eCOA process
  • Can technology play a pivotal role in achieving better outcomes?
  • Benefits of Decentralized Clinical Trials revolutionizing the way research is conducted
  • Key Components of Decentralized Trials reshaping the traditional model
  • Ethical standards and participant safety as crucial cornerstones of the research effort
  • Challenges and barriers in clinical research
  • Principles for successful Decentralization in Clinical Trials

PATIENT ENGAGEMENT & COLLABORATIONS

  • Transformative potential of decentralized clinical trials in addressing the limitations of traditional randomized controlled trials
  • Utilizing remote digital technologies and community providers to enable broader, more inclusive participation
  • Potential of DCTs for democratizing clinical research
  • Research needed to devise standardized protocols to streamline DCT processes, explore its long-term
    impacts on patient outcomes, and overcome challenges through equitable stakeholder engagement.
  • The aim of decentralised trials in patient centricity, enhanced efficacy in clinical trial conduct and generating real-world data
  • Finding what is a true patient-centric approach and understanding what patients really want
  • Incorporating patient voice in designing clinical trials
  • How does DCT and Hybrid trials overcome hurdles in recruitment and retention
  • Key elements that need to be in place in a DCT setting to ensure good levels of patient retention.
  • Incorporating DCT elements into hybrid models
  • Explore the role of DCTs in offering flexible options for the patient
  • Addressing disparity in clinical trial representation
  • Opportunities for DCT approaches to improve inclusivity
  • Challenges and opportunities for researchers to adopt and adapt DCT approaches
  • Factors enhancing the inclusion of marginalized and vulnerable populations in trials
  • Clinical trial strategy planning in the new era of digital health
  • Cost drivers of potential cost savings
  • Sponsor cost and budget considerations
  • Budget trends in DCTs and virtual clinical trials
  • Importance of strong relationship with sit and site network critical to the success of clinical trials
  • Strategies sponsors can develop to build strong site relationships at scale.
  • Key factors that are highly valued by both Contract Research Organisations (CROs) and Sponsors.
  • Future directions for improving relationships with sites and site networks.

The Future of Real-World Evidence

  • Remote method of trial delivery
  • Open access toolkit of resources and guidance for researchers to support the transition to remote delivery
  • Expanding UK capabilities in decentralized trial delivery
  • Decentralized clinical trials: case studies
  • Addressing structural barriers and how we get improved access to clinical trials
  • Impact of incorporating decentralized elements into clinical trials on data integrity, patient safety, and regulatory approvals.
  • Additional initiatives aiming to extend access and inclusion in clinical trials
  • Fostering partnerships to increase patient and local clinician access to the clinical trials
  • Practical applications of how to implement meaningful and consistent Patient Engagement
  • The value of co-creating a clinical outcome assessment strategy for clinical trial research
  • Next step toward delivering the best possible research experience for patients by co-creating studies with patients.
  • Challenges facing the adoption of decentralized trials
  • Approaches for decentralized trials as well as key performance indicators
  • Best practices that reduce risk and improve the execution of decentralized clinical trials
  • Availability of educational resources for all stakeholders and advance a supportive culture and environment to increase uptake of decentralized research
  • Recognise remaining barriers to the global conduct of decentralized trials and map route to resolution

Moderator:

Panelists:

Decentralized & Hybrid Clinical Trials World Congress 2025 Europe

Co-located with the Patient Centricity & Collaboration World Congress 2025 Europe 

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£499
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  • All Day Refreshments & Lunches
  • Conference Documentations
  • Networking Drinks Reception

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Thank you for a good experience with the PARADIGM Global Events… very high level, very good Organization, we overpassed our expectatives, we will be pending for another congress related to pharmaceutical and biotech… we learned a lot, and i think that the content of agenda was state of the art, thank you again.
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The consistently high quality of international faculty was most impressive. It was also obvious that they were carefully chosen not only for their particular expertise but also for their ability to communicate the subject matter to clinical and non-clinical participants alike. As market access consultant for pharma clients of various sizes, I now feel much better prepared to explain the nuances & dynamics involved in bringing their products to market. In addition, I am in a much better position to intelligently advice my clients & help them set realistic expectations
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Adriana E. Manzi
PhD, Managing Director, Atheln, Inc

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