Live-Webinar on 23-NOV-2026 at

02:00 pm (CET) | 08:00 am (ET)

For all Clinical Operations Professionals involved in Clinical Trials with Medical Devices:

From Injection to Insight:

How Connected Drug Delivery Can Improve Clinical Trial Execution

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A focused expert webinar for Clinical Operations professionals who want practical exchange, fresh perspectives, and concrete implementation questions for connected injection in clinical trials.

Join this online session to discuss where connected injection may add value, what evidence is needed to assess return on investment, and what your team should clarify before implementing connected technology in a clinical trial.

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23-NOV-2026 at 02:00 pm (CET) | 08:00 am (ET)

Live online via Microsoft Teams

Hosted by Clinical Excellence GmbH

With Ypsomed AG as co-host

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Who Is This Webinar For?

This expert webinar is designed for:
  • Heads and Directors of Clinical Operations
  • Clinical Project Managers
  • Clinical Programme Leaders
  • Digital Clinical Trial Leads
  • Decentralized Clinical Trial Leads
  • Clinical Data Management Leaders
  • Device specialists

FROM Limited Visibility to better clinical Trial Decisions

In many clinical trials involving self-administration, sponsors rely on indirect, delayed, or incomplete information to understand whether participants administered the investigational product as planned.

  • Was the injection performed at the intended time?
  • Was the administration completed?
  • Was the device used as intended?
  • Does an observed result relate to the treatment, the product or an administration issue?
  • Does the participant or site require additional support?

A missed, delayed or incorrectly performed injection may remain unidentified until the next site contact, monitoring review or data analysis.

This creates an invisible adherence and administration gap.

Clinical Operations teams are then asked to assess efficacy, safety, protocol compliance, participant support needs, and sponsor oversight requirements without reliable event-level information.

Connected drug delivery technology can provide additional administration data. However, the device alone does not create operational value.

 Value is created when relevant data are integrated into clinical trial workflows, discussed across functions, and converted into information that supports participant care, site follow-up, data review, risk management, and sponsor oversight.

Ist This a Challenge Your Team Is Facing?

  • You are considering self-administration, decentralized or hybrid elements in a clinical trial, but your team has limited visibility of what happens between scheduled participant contacts.
  • You want more reliable adherence information, but you are unsure which data would be meaningful and how those data should be used.You are evaluating connected technology, but the responsibilities of the sponsor, sites, device provider, technology partner, and service providers have not yet been defined.
  • You need to involve Clinical Operations, Data Management, Quality, Regulatory, Data Privacy, Security, and Device stakeholders, but the functions do not yet have a common planning framework.
  • You want to assess the potential operational and economic value of connected injection, but the required baseline, evidence, and success measures remain unclear.
  • You need a setting that supports honest expert exchange rather than a one-way technology presentation.
Most importantly, you want to determine whether connected injection addresses the operational needs in your clinical trial.

What If Your Team Could Discuss the Opportunity More Systematically?

Imagine having a clearer understanding of:

  • The adherence and administration problem that connected injection could address
  • The additional information that a connected autoinjector may provide
  • The decisions that device-generated data should support
  • The clinical trial workflows that may be affected
  • The functions and partners that need to be involved
  • The evidence required to assess operational and economic value
  • The responsibilities that should be defined before implementation
  • The circumstances in which connected injection may not be the appropriate option

This webinar is designed to support those discussions.

It provides a structured basis for assessing where the technology may add value, what evidence is required, and what should be planned before implementation, with room for practical questions from the Clinical Operations community.

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What Awaits You in This Webinar

1. Understand the Invisible Adherence Problem

Consider what sponsors may not currently be able to see or verify when participants self-administer an investigational product.

The expert discussion will examine where conventional assumptions, retrospective reporting, or scheduled site contacts may leave important visibility gaps.

2. Understand Why Adherence Visibility Matters

Explore how missing, incomplete, or delayed administration information may affect:

  • Protocol compliance review
  • Participant follow-up
  • Safety interpretation
  • Efficacy interpretation
  • Data review
  • Risk management
  • Operational decisions
  • Sponsor oversight

3. Assess Where Connected Injection Fits

Examine the position of connected injection within participant, site, and sponsor workflows.

Ypsomed will use CliniPilot, the connected add-on for YpsoMate and YpsoMate 2.25 autoinjectors, as a practical case example to illustrate connected injection in a clinical trial context.

The discussion will focus on the sponsor problem, available evidence, workflow considerations, and implementation requirements rather than presenting the webinar as a product demonstration.

4. Understand How Device Data Becomes Actionable Information

Collecting data is not enough. The webinar will consider the decisions required around data capture, system interfaces, access controls, review responsibilities, operational follow-up, and sponsor oversight.

5. Take a Structured Next Step

Leave the webinar with a clearer basis for discussing connected injection with internal stakeholders, device providers, technology partners, and service providers.

The webinar follows a problem, consequence, evidence, workflow, sponsor assessment, implementation and action sequence.

What You Can Expect from the Webinar

Multiple Expert Perspectives

The discussion is designed to connect Clinical Operations, device and workflow expertise, data and adherence expertise, and pharmaceutical sponsor decision-making.

This cross-functional format reflects the reality that connected-device implementation cannot be assessed by one function alone. It also mirrors the purpose of the Clinical Operations Roundtable: bringing peers and experts together to discuss real-world challenges and practical solutions.

Evidence-Conscious Communication

The speakers will distinguish between approved evidence, operational experience, implementation assumptions, and questions that still require assessment.

Quantitative, clinical, operational, and economic statements will require supporting evidence and appropriate review.

Practical Implementation Considerations

The webinar will move beyond the question of whether the technology exists.

It will address what is required to integrate connected injection into the wider clinical trial workflow.

Audience Questions

Participants will have an opportunity to raise questions during the webinar, subject to the final event format.

Priority will be given to questions that help assess evidence, feasibility, implementation readiness, and practical implications for clinical trial teams.

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Jessica Cordes, Managing Director of Clinical Excellence GmbH

Your Host:

Jessica Cordes (Clinical Excellence GmbH)

Jessica Cordes has worked in clinical research for more than 15 years and supports Clinical Operations professionals and small biotechnology companies in strengthening quality, operational clarity, and practical execution in clinical trials.

Through Clinical Excellence GmbH, Jessica provides consulting, training, templates, and expert formats that help teams translate complex clinical trial requirements into workable processes.

With the Clinical Operations Roundtable, she creates a professional space for focused expert exchange, practical peer learning, and concrete discussion of current Clinical Operations challenges.

Jessica combines an understanding of clinical trial challenges with structured, practical support adapted to the needs of clinical research teams.

Your Co-Host:

Tobias Theiler (Ypsomed AG)

Device and Workflow Perspective

Tobias Theiler discusses connected injection in the clinical workflow by using CliniPilot as a practical case example.


Speaker: Tobias Theiler, Head of Human Factors & Medical Affairs

Tobias Theiler is Head of Science, Human Factors, and Medical Affairs at Ypsomed AG. Before joining Ypsomed in 2022, he held research and development positions at University Hospital Aachen, BIOTRONIK in Berlin, and Abbott Medical in Zurich.

He holds a BSc in Physics and an MSc in Electrical Engineering from Ruhr University Bochum, as well as a doctorate in Medical Sciences from RWTH Aachen University. He has co-authored peer-reviewed publications on cardiac implantable medical devices, electromagnetic interference, and human factors in self-injection systems.

Sponsor Perspective

Rea Lehner (Roche)

Rea explains practical decision criteria, evidence expectations, internal requirements, and potential implementation barriers.


Speaker: Rea Lehner (Global Clinical Operations Excellence Leader - Digital Innovation)

Dr. Rea Lehner is a digital health leader dedicated to transforming clinical trials through technology, data-driven solutions, and cross-functional collaboration. As Global Clinical Operations Excellence Leader at Roche, she leads the adoption of clinical technologies and AI to accelerate trial delivery and execution.
Her previous experience spans leading digital biomarker development and integration across Phase 1–4 studies at Roche and serving as Associate Director for Future Health Technologies at the Singapore-ETH Centre. Rea holds a PhD in Health Sciences and Technology from ETH Zurich, serves as an Expert for Innosuisse (Swiss Innovation Agency), and lectures on digital health technology at ETH Zurich.

Site Perspective

Prof. Michel Burnier (University of Lausanne)

Prof. Burnier provides the clinical trial site perspective on the practical requirements, evidence needs, and operational challenges associated with connected drug delivery devices.


Speaker: Prof. Michel Burnier (Honorary Professor of the Service of Nephrology and Hypertension)

Michel Burnier is MD, Emeritus Professor at the University of Lausanne and former Head of the Service of Nephrology at the University Hospital of Lausanne, Switzerland. He has led a research group working in the field of hypertension and the kidney for many years.
Past president of the Swiss Society of Hypertension and of the Swiss Society of Nephrology, he has been a member of the Council of the European Society of Hypertension for several years and is now the treasurer of Foundation of the European Society of Hypertension.
He is also the Editor in Chief of Blood Pressure. M. Burnier is still involved in hypertension research with main research interests being the development of new drugs for the treatment of hypertension and kidney diseases and medication adherence.

Data and Adherence Perspective

Bernard Vrijens (AARDEX Group)

Dr. Bernard Vrijens discusses the data flow, integration, interpretation, and oversight considerations needed to convert device data into usable information.


Speaker: Bernard Vrijens, PhD (CEO & Scientific Lead)

Dr. Vrijens earned his PhD from the Department of Applied Mathematics and Informatics at Ghent University. He is internationally recognized as a pioneer in the science of medication adherence, having developed a robust taxonomy of medication dosing errors and advanced measurement-guided medication management approaches designed to improve adherence and long-term persistence.
Dr. Vrijens has authored more than 150 scientific publications, holds multiple international patents in the field of medication adherence measurement and digital health technologies, and has been consistently recognized among the world's leading researchers in his discipline. He is ranked among the top 2% of scientists worldwide in the Stanford University/Elsevier global scientific impact rankings.
A founding member and former president of ESPACOMP (the International Society for Medication Adherence), Dr. Vrijens has played leading roles in numerous European and US-funded research collaborations focused on medication adherence, digital health, and patient-centered healthcare innovation.

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Frequently asked Questions

Will This Be a Product Presentation?

No. The webinar discusses a practical sponsor problem and then addresses evidence, workflow, data, sponsor decision criteria, and implementation considerations.

Ypsomed will contribute subject-matter expertise and use CliniPilot as a case example, but the session is intended as educational decision support rather than a product-led presentation.

We Are Not Currently Selecting an Autoinjector. Is This Webinar Still Relevant?

Yes, if your work involves self-administration, connected devices, adherence visibility, remote monitoring, or device-generated data. The session is intended to help teams consider relevant questions before a technology or a provider is selected.

We Already Monitor Adherence. What Additional Value Could Connected Injection Provide?

The relevant question is whether current information is sufficiently timely, objective, and suitable for the decisions your team needs to make.

The webinar will help participants assess whether additional event-level information could address a specific visibility gap or whether it would introduce unnecessary complexity.

Connected Technology Sounds Operationally Complicated. Will the Webinar Address This?

Yes. The webinar will consider workflow integration, data interfaces, participant and site support, review responsibilities, sponsor oversight, risk, compliance, timelines and continuity. The purpose is not to minimize implementation complexity. It is to make the important questions visible early enough to support an informed decision.

Is the Webinar Relevant to Small Biotechnology Companies?

Yes. The intended audience includes small and mid-sized biotechnology and pharmaceutical sponsors considering self-injection, connected devices or remote monitoring. Early identification of responsibilities, resources and partner dependencies may be particularly important for companies with limited internal capacity.

Can I Submit a Question in Advance?

Yes. Please submit your questions directly to the moderator by email to Jessica.Cordes@clinical-excellence.com

Will a Recording Be Available?

The webinar will be recorded and will become available to you.

Is Participation Free?

You can participate for 0 Euro.

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23-NOV-2026

at 02:00 pm (CET) | 08:00 am (ET)

- online via Microsoft Teams -


From Injection to Insight: How Connected Drug Delivery Can Improve Clinical Trial Execution

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