TwoKnct Media & Publishing

Advancing Investigator-Led Clinical Research Through Collaboration, Quality & Innovation

Investigator-Initiated Trials Conference

Join us in The Investigator-Initiated Trials Conference brings together academic investigators

As investigator-initiated trials (IITs) play an increasingly important role in addressing unmet medical needs

Welcome to TheInvestigator-Initiated Trials Conference 2026Β β€” The Investigator-Initiated Trials Conference brings together academic investigators, clinical researchers, hospital research offices, industry partners, CROs, and regulatory stakeholders to explore best practices and emerging approaches in investigator-led clinical research across Europe.

As investigator-initiated trials (IITs) play an increasingly important role in addressing unmet medical needs, generating real-world evidence, and advancing clinical practice, there is growing demand for practical guidance, regulatory clarity, and sustainable collaboration models.

This conference is designed as a focused, discussion-driven forum, moving beyond theory to address the real-world challenges of designing, funding, managing, and scaling investigator-initiated trials within the European regulatory and institutional landscape.

Eric HALIOUA

President & Chief Executive Officer PDC*line Pharma

Christopher P. Locher

CEO and co-founder Versatope Therapeutics

Kinkini Roy

Associate Director, Formulation Development AVICEDA THERAPEUTICS INC

Ilya Vensky

General Partner Provisio Ventures

LΓ©lia Delamarre

Distinguished Scientist in Oncology Discovery Genentech.

Sean Bedingfield

Senior Advisor Eli Lilly & Co

View The Full Programme

Who Should Attend

  • Principal Investigators & Academic Clinicians
  • Hospital & University Clinical Research Offices
  • Clinical Trial Managers & Study
  • Coordinators Biostatistics & Data Management
  • Professionals Medical Affairs & Clinical Operations (Pharma & Biotech)
  • CROs Supporting Investigator-Initiated Trials
  • Ethics Committee & Regulatory Affairs
  • Professionals Research Funding Bodies & Clinical Research Networks

Industries Represented

  • Academic Medical Centers& Universities
  • Hospitals & Healthcare Providers
  • Pharmaceutical & Biotechnology Companies
  • Contract Research Organizations (CROs)
  • Medical Device & Diagnostics Companies
  • Digital Health & Clinical Trial Technology
  • Providers Regulatory & Ethics Bodies
  • Public Research Networks & Funding Organizations

Key Themes

Investigator-Initiated Trial Design & Methodology

  • Designing scientifically robust investigator-led studiesΒ 
  • Protocol development, feasibility, and endpoint selectionΒ 
  • Avoiding common design and execution pitfalls

Regulatory, Ethics & Governance in Europe

  • Navigating EU Clinical Trials Regulation and
  • CTIS Ethics committee submissions and approvals
  • Clarifying investigator and sponsor responsibilities

Funding, Budgeting & Financial Oversight

  • Public grants, foundations, and industry support models
  • Budget planning, cost control, and transparency
  • Contracting and financial governance for IITs

Trial Operations & Quality Management

  • Study start-up, site management, and coordination
  • Risk-based monitoring approaches for IITs
  • Ensuring GCP compliance and audit readiness

Industry, CRO & Academic Collaboration

  • Best practices for supporting IITs while preserving independence
  • Effective pharma-academic and CRO-academic partnerships
  • Outsourcing strategies for investigator-led studies

Data, Evidence & Publication

  • Data integrity, ownership, and access
  • Statistical analysis and reporting
  • Publication ethics and dissemination of results

Future Trends in Investigator-Initiated Trials

  • Digital and decentralized trial approaches
  • Multi-country collaboration in Europe
  • Building sustainable investigator research ecosystems

mRNA design and optimization

Stability, translation efficiency, and immunogenicity

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6 Key Themes for Investigator-Initiated Trials Conference

Investigator-Initiated Trials Conference

  • Gain Practical Guidance for Investigator-Led Trials: Learn how to design, fund, and manage investigator-initiated trials with real-world insights from experienced investigators and trial professionals.
  • Navigate European Regulatory & Ethics Requirements: Understand how to work effectively within EU Clinical Trials Regulation, CTIS, and national ethics frameworks.
  • Strengthen Academic–Industry Collaboration:Β  Explore transparent, compliant models for collaboration between investigators, pharma, CROs, and research networks.
  • Improve Trial Quality & Operational Execution: Discover best practices for monitoring, data management, and quality assurance in investigator-initiated studies.

  • Prepare for the Future of IITs: Gain insight into digital tools, decentralized approaches, and evolving expectations shaping investigator-led research.

  • Network with the Investigator-Initiated Trials Community: Connect with peers, experts, and stakeholders actively shaping the future of investigator-led clinical research in Europe.

Investigator-Initiated Trials Conference

Investigator-Initiated Trials Conference β€”Β  This conference is designed as a focused, discussion-driven forum, moving beyond theory to address the real-world challenges of designing, funding, managing, and scaling investigator-initiated trials within the European regulatory and institutional landscape.

Investigator-Initiated Trials Conference

Get in touch for Group Discounted Tickets

Book An Exhibition Stand + 2 Delegate Passes: Book Now For Just: 4,999 €

Discover how you can be a part of this exciting conference and get your expertise in front of your target audience. Packages Include; Exhibition Area, Main Stage Speaking, One-To-One Meetings.

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Get in touch for Group Discounted Tickets

To register your team now and benefit from huge group savings, call the conference team on +420 776 164 009 (Prague office) || +44 2038 076 227 (London office)

* We hope you’d like to hear about! We will use your information to predict what you might be interested in.

Venue Details

Hotel SB Plaza Europa

Lisbon, Portugal

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