Next month, senior-level speakers from leading pharma companies such as Roche, AstraZeneca and Novartis, along with speakers from emerging biotechs and patient advocacy groups, will come together at the Outsourcing in Clinical Trials DACH (OCT DACH) conference.
The meeting, which will take place on 3 and 4 November in Basel, Switzerland, will allow attendees to discuss the evolving clinical trial landscape in Europe, with a strong focus on partnerships, regulations, artificial intelligence (AI) and patient engagement.
The conference will kick off with a keynote by Sofia Ribeiro Forte, VP, head of clinical operations and Dominik Hartl, CMO at Granite Bio, examining the challenges and opportunities facing biotech clinical drug development. The pair will explore how clinical trial sponsors can allocate resources to accelerate development without compromising quality, and where companies should build capabilities internally rather than rely on external partners.
The discussion around Europe’s clinical research environment will continue with a panel examining how geopolitical and regulatory dynamics are reshaping the selection of clinical trial destinations. The panel will centre on why Europe risks losing competitiveness despite its established healthcare systems and research reputation, as well as examine initiatives including FAST EU, COMBINE and the EU Biotech Act that aim to retain Europe as a desirable clinical trial destination.
Following the morning sessions, on the first day the conference will divide into two streams, with one focusing on “Outsourcing and Clinical Operations” (Stream A) and the other examining “Data, AI and Clinical Innovation” (Stream B).
Exploring AI in clinical trial operations and rethinking outsourcing partnerships
In Stream B, Marta Batlle López, responsible AI and GenAI lead at Roche, will explore the building of responsible AI systems for life sciences. The session will focus on AI governance, transparency, regulatory compliance and risk mitigation, while also considering how companies can prepare for increasingly autonomous AI systems without losing human oversight and accountability.
AI and evidence generation will remain central to the data and innovation stream, with Mariana Spínola, senior clinical specialist at Biorce, following up with a talk on how AI can help address trial design issues and reduce protocol amendments, while Florian Vogl, fractional CMO at Stealth Mode Biotech, will discuss evidence strategies incorporating patient-centred endpoints, biomarkers, innovative trial designs and real-world evidence.
In Stream A, the changing relationship between sponsors and CROs will be scrutinised during a live debate on whether large CRO operating models are equipped to meet the agility and priorities of smaller biotechnology companies. Juliet Dizon of ARTBIO and Antje Hindahl, head of strategic clinical vendor management at Argenx, will examine the differences between traditional and niche CRO models, as well as how specialist vendors are responding to sponsor demands for more tailored and flexible support.
AI will return to the agenda later in the day with a panel in Stream B examining whether today’s AI strategies can withstand the future demands of clinical development, where panellists will explore how organisations can move beyond disconnected AI applications towards more integrated approaches.
Patient centricity will also be a recurring theme throughout the first day. In Stream A, Karen Cheng, patient advocate at The Myositis Association, will discuss how engaging patients earlier in clinical development can improve trial relevance, feasibility and quality.
Regulatory expectations and site capacity take centre stage
The second day will commence with interactive breakout discussions covering the operationalisation of technology and AI, evolving US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, next-generation outsourcing models and common shortcomings in patient-centred clinical research.
Later, a keynote will examine common Good Clinical Practice (GCP) and practical lessons in clinical research. Site capacity and patient recruitment will subsequently take the spotlight in a panel discussion asking whether sponsors are placing sites under unsustainable pressure. Speakers from Roche, Viatris, The Myositis Association and Novartis will discuss why recruitment forecasts and feasibility assessments in the DACH region continue to miss targets despite its established research infrastructure.
Daniel McVeigh, director, clinical operations at Alexion Pharma, will later examine how Phase IV research is changing in an environment increasingly shaped by external control arms and strategic outsourcing. The conference will conclude its patient-focused discussions with a closing keynote from Ivo Schauwecker, President of EUPATI Switzerland and head of research ethics at ETH Zürich, examining how patients can participate as equal partners throughout medicines development.
Across the two days, Outsourcing in Clinical Trials DACH will bring together discussions around many of the pressures currently affecting clinical development, from European trial competitiveness and regulatory change to CRO partnerships, patient and site engagement, evidence generation and the growing role of AI in trial design and execution.
The 9th Annual Outsourcing in Clinical Trials DACH 2026 conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology.
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