Overview
In this webinar, ICON will provide insights on the Decentralised Clinical Trial (DCT) landscape, including definitions, regulatory framework, elements of decentralization and operational best practices. This webinar will seek to address many questions around what DCT is and best practices for implementing this in the drug development pathway.
Time |
Subject name |
Objectives |
Targeting contents |
Speaker |
|---|---|---|---|---|
| 09:00~10:00 | DCT Element -DHT | Defining what is a DCT versus a hybrid | Types of clinical trials | Kimberly Dley |
| 10:00~11:00 | DCT Element – Community Research | Looking at best approach to community research | Community Research | Darlene Ellenor |
| 11:00~12:00 | DCT Element – DHT | Looking at Digital Health Technologies | Digital Health Technology | Keith Thomas |
|
12:00~13:00 |
DCT Element – Digital Platforms | Best practices for evaluating digital platforms | Digital Platforms | Alex Crawford |
| 13:00~14:00 |
Lunch |
|||
| 14:00~15:00 | DCT – Bringing it all together | Operationally review and deploying fit for purpose DCT elements | Operationalization | Cristobal Castillo |
Speakers
Emily Mitchell
Executive Director, Decentralised Clinical Trials Operations, ICON plc
Emily Mitchell has over 15 years of experience in the CRO industry, working across multiple functions including Data Management, Project Management and Clinical Operations. During her time at ICON, Emily partnered with Actigraph to run a pilot study with employees on the wear compliance and comparison of a medical grade activity tracker to commercial grade devices. Just prior to the pandemic, Emily managed the set-up and support of the first fully decentralised clinical trial to have published positive results in a peer reviewed publication, Nature.
Emily has presented on the best practices in decentralising studies, ensuring patient and site burden is minimised while optimising data capture, at numerous industry forums and conferences. She is an active member of SCDM and continues to support the progression of the industry in this innovative space.
Kimberly Dley
Business Operations Manager, Decentralized Clinical Trials Operations
Kimberly has 10 years of CRO experience, spanning across biometrics, project management and business operations roles.
Kimberly oversees the implementation of DCT strategy and solutions for hybrid in-flight trials and has been a project manager during the start-up of a full DCT. She also provides consultative guidance to embed DCT elements to add value to trials. Finally, Kim is an active contributor in developing and change management of operational processes to set trials teams up for success in deploying DCT strategies.
She holds a Master of Business Administration specialized in Digital Transformation, a Bachelor of Science degree in Biology, and is a certified Project Management Professional.
Darlene Ellenor
Director of Project Operations, Decentralized Clinical Trials Operations
Darlene has been working in the Clinical Trials industry for over 14 years, including 10 years in Project Management and 1.5 years in the Decentralized Clinical Trials Operations department.
Darlene oversees the Project Management team working on fully decentralized clinical trials at ICON. She has worked on 3 fully decentralized studies as a Director of Project Delivery. She also leads the team creating/modifying tools and templates for Project Managers to lead decentralized clinical trials.
She holds a Master of Science degree in Medical Genetics and is a certified Project Management Professional.
Keith Thomas
Senior Director, Decentralised Clinical Trials Solutions
Keith directs the strategic planning and operational use of digital health technologies, digital biomarkers, and digital endpoints for clinical trials at ICON. His background gives him unique insight into both the technical aspects underlying digital health technologies, as well as first-hand experience with real world usage. He leverages this experience to devise successful strategies for clients.
Prior to joining ICON, Keith held product and program management roles, driving the successful integration, deployment, and utilisation of digital health technologies in remote patient monitoring, virtual care and clinical research applications. Earlier in his career he held positions at medical device and digital health organisations, focusing on the design and development of hardware, firmware, and software for a variety of digital health technologies.
Keith holds a Bachelor of Science degree in Computer Engineering.
Alex Crawford
DCT Product Director, Decentralized Clinical Trials Operations
Alex Crawford has 15 years of experience working with clinical technology spanning across multiple Decentralized, Data Management, and Clinical Operations applications. During his time at ICON, Alex has worked to expand partnerships with existing DCT vendors and has played an important role in the growth of ICON’s home grown technology suite.
Alex has presented on DCT technology methodologies for SCDM and has spoken at numerous conferences around eSource and DCT technology selection.
Cristobal Castillo
Director of Project Operations, Decentralized Clinical Trials Operations
Cristobal has over 23 years in clinical research staring as a CRA and moving up to Director. He has mainly worked in Oncology. Cristobal has recently moved to the Decentralized Operations department.
Cristobal works with the business department in proposals for our potential clients, analyzing the potential of each protocol for decentralization and proposing strategy and budget. He is also involved in several internal initiatives to develop and improve our processes in a ever changing environment.
Cristobal has a Pharmacy Degree and a Master in Clinical Trials and Project Management. He is based in Spain.