Decentralized Clinical Trials: Implementation of a Hybrid Model from a Site and Sponsor Perspective

Running Decentralized Clinical Trials (DCTs) is a new and complex challenge for most of the stakeholders within the pharmaceutical industry. There are a lot of theoretical discussions and multiple approaches to conducting DCTs, but it’s most useful to see how they are implemented from a real operational perspective. What is the impact on the Patients? What is their perspective? Is it possible to create a simple, effective and feasible approach to DCTs?

This webinar will focus on discussing the flexible tools necessary for adapting work to a number of different clinical trial models, including site-based, hybrid and virtual trials.

The speakers will each share insights on DCTs from their unique areas of expertise: the operational point of view, the Patient perspective and an eye to the future from a sponsor company.

Key questions to be answered will include:

• What are the challenges of DCTs for sites and sponsors?
• What are the new roles for sites and PIs (e.g., Patient oversight, assistance and home visits)?
• How can staff better meet the needs of Patients through DCTs (e.g., improving access to trials, Patient journey and retention)?
• How will DCTs change the collaboration between sponsors, PIs and sites?

Register for this webinar to learn how to solve some of the most common challenges of running Decentralized Clinical Trials to ensure the needs of Patients, sites and sponsors are met.

Speakers

Dr. Ole Dammann, CEO, kfgn I Site Operations & Services; Board Member, Country Head Germany, Pratia S.A.

Dr. Ole Dammann is the country head for Germany and board member of Pratia S.A. At Pratia, he is also involved in the digitization of clinical research and the development of new business models. Ole is engaged in several projects in digital healthcare. They focus on the validation of digital health apps as well as diagnostic solutions. He has a deep understanding of clinical research and the clinical research market. Before joining kfgn, Ole worked in various positions in the chemical and healthcare industry with the latest positions in finance. He holds a master’s degree in business (Dipl.-Kfm.) and a Ph.D. in Organization from the University of Mannheim with a research stay at Stanford University.

Message Presenter

Karl-Ludwig Radek, Internal Project Lead for IMI TRials@Home, The Janssen Pharmaceutical Companies of Johnson & Johnson

Karl is an economist by training and certified financial advisor. After several years working in the public healthcare sector in Germany, he joined J&J in Germany in 2015. Although he has no direct clinical operations background, one of his key strengths is to see things differently. In his current role, he is responsible for establishing and managing relations with site networks across Europe, the Middle East and Africa. In addition, he is also the Janssen project lead for the IMI project Trials@Home. In 2020/2021 he was also a member of the European Health Parliament – a group of next-generation healthcare leaders that is developing healthcare policies for better healthcare provision in Europe.

Message Presenter

Michał Kwiatek, MD, PhD, Investigator, Site Director, Pratia S.A.

Michał is a hematologist who specializes in lymphoproliferative diseases. Medical director of the PRATIA POZNAŃ clinical research center, as well as a co-founder of two medical start-ups: BADANIA.pl and NEO-INSIGHT.

Message Presenter