Workshop:
Digitalized Clinical Trials - Planning and Design

 To successfully address the digitalization of the clinical trials, we need to start from the beginning. This requires a thorough planning and design of the standards and metadata, which drive the conduct of the clinical trial. Even more, clinical trial metadata and standards are key elements of the various Clinical Operations processes of the required clinical trials of the entire drug development project. A comprehensive understanding of entire drug development program, its metadata and standards comes to the forefront.

Digital Clinical Trials basically are being managed in their metadata and executed in their standards. Digitalization has the potential to increase the trial productivity and lower costs by connecting downstream processes to end-to-end processes and enabling an early and comprehensive insight on the compound in the Clinical Development Project through well-defined metadata and standards applicable across the trials. More information is available below.

In this workshop you will have the opportunity to discuss with other attendees approaches and concepts to implement the use of digital technologies in clinical trials. We also take the risks and benefits in consideration. We will progress in the understanding of Clinical Trial Digitalization benefits at the early stages of Planning and Design. Furthermore, we give you a simple tool at hand to determine the Clinical Process Maturity in your organization and identify appropriate next steps to motivate the next maturity level.

This inspiring and interactive workshop provided by our partner Intilaris LifeSciences will be online and live via zoom on Thursday 17 June 2021, 16:00-18:00 CET. The content of the workshops is provided for for free. However, we ask a small fee of € 25,- (including VAT) for registration and administration. This also assures a dedicated audience during the workshop. You can register for this workshop via the Register button below.

 

More information 

Clinical trials are an essential tool used to evaluate the efficacy and safety of new drugs and medical devices. The concept of clinical trials is a success funnel for the development of new drugs, devices and healthcare system interventions. The emerging industry trend of “digitized clinical trials” leverages digital technology across the setup, conduct and closure. Technology enables to connect and synchronize downstream processes for consistency, quality, performance, and productivity purposes. Yet, it also can be utilized to improve participant access and engagement, patient randomization, trial data collection and many more to transform clinical trials and to lower the cost.

To successfully address the digitalization of the clinical trials, we need to start from the beginning. This requires a thorough planning and design of the standards and metadata, which drive the conduct of the clinical trial. Even more, clinical trial metadata and standards are key elements of the various Clinical Operations processes of the required clinical trials of the entire drug development project. A comprehensive understanding of entire drug development program, its metadata and standards comes to the forefront.

What are the metadata and standards of Clinical Trials? Metadata describe the structure and content of the collected data. Metadata are the basis to determine meaning, content, and relations in the data. Metadata describe data concepts like efficacy, safety, and patient population data items and how those data points can be interpreted. Metadata help to recognize the forest from the trees. Standards are the basis to determine the measurement, the range, the units, the relationships between data items and how the data points need to be created. Standards help to determine the tree in the forest. Together they form a critical building block towards digitalization.

Data Managers in Clinical Operations organizations are the experts and ensure the practicability and processibility of metadata and standards in Clinical Trials. Concepts of traditional clinical trials are focused on the operational trial conduct and the suitability of collected data to meet the trial objectives. Yet, a successful drug development project requires a sequence of Clinical Trial with different objectives. The identification of an initial safety profile of a compound requires a meta-analysis of all safety data across the conducted trials. Metadata and standards are here key to compare, and merge collected data and consolidate the safety profile. 

Digital Clinical Trials basically are being managed in their metadata and executed in their standards. Digitalization has the potential to increase the trial productivity and lower costs by connecting downstream processes to end-to-end processes and enabling an early and comprehensive insight on the compound in the Clinical Development Project through well-defined metadata and standards applicable across the trials.

 

About the trainer(s):

Torsten Friedel, Dipl.-Ing. (TH),
M.Sc. Strategy Consultant, Project Manager, Business Process Analyst

Experienced Strategy Consultant focusing on innovations, digitalization, and process integrations in Clinical Development in Top 20 pharma organizations. Delivering strategy consulting, project management and business process analysis.

Innovating Clinical Trials, Clinical Operations and Drug Supply processes. Introducing technology for sustainable value for our pharma clients. Throughout my career I worked on delivering strategies, innovations, and process optimizations in Pharma Industry with focus on Clinical Development, and improvements through Clinical Technology and Processes in Top 20 companies.

Co-founded intilaris LifeSciences in 2013 and serving since as Managing Director of this Basel-based Life Science and Pharma consultancy.

Djenan Ganic, Ph.D. Project Manager, Solutions Architect, and Principal Consultant

Experienced Project Manager, Solution Architect and Life Sciences Consultant, with a passion for transforming pharma business processes through technology and digitalization. Applying expertise for 17+ years in designing and implementing professional and reliable solutions, ensuring compliance with industry regulations, validating GxP systems and bringing innovations to clinical development.

Throughout my career I worked on delivering solutions, process optimizations, innovations in Pharma Industry with focus on Clinical Development, and improvements through Clinical Technology and Processes in large pharma companies. I am certified Enterprise Architect (TOGAF), ITIL, J2EE, and Oracle LSH and have worked in projects applying V-models and AGILE principles (SCRUM).

Author of 12 refereed journal papers, and regular presenter at conferences: OHSUG, PhUSE, CDISC Interchange, Oracle Open World, Evolution of Clinical Data Management, etc.