Agility for Rare Disease and Oncology Clinical Trials – Data Management

Wednesday, April 03, 2019 | 9am EDT (NA) / 2pm BST (UK) / 3pm CEST (EU-Central) 60 min

Join this live 1-hour webinar to review  strategies for data management in modular and adaptive clinical trials. Register here.

Modular and adaptive clinical trials are rapidly expanding the ability of researchers to modify clinical trials based on emerging data, i.e. to make better decisions based on positive clinical response. This is a flexible process which provides data on the smallest number of patients so that drug developers can pre-plan alternative paths for the trial during the design stage.

In this session, attendees will:

  • Learn how to reduce study build times by up to 30 percent, reducing cost while increasing quality, achieving clinical site set-up faster
  • Learn how a cloud platform enables mid-study changes without the need to migrate data  reducing risk and impact on trial success, trial teams, and trial execution
  • Gain insight on how adaptive, lean and flexible operational conduct from a CRO study team enables adaptive data management
  • Review timelines and flexible build process to include challenges experienced and ways to mitigate those challenges
  • Understand how to execute oversight requirements under GCP E2 R2 using online tools

Speakers

Robin Clark, Principal Data Manager, Simbec-Orion Group

Robin Clark has 18 years of clinical data management experience having worked with a number of pharmaceutical companies and CROs in the UK, Germany and the Netherlands. He has had a wide range of study experience covering all major therapy areas. Robin graduated from the University of Liverpool with a Bachelor of Science (Honours) in Zoology

Ralph Johnson, Principal Sales Consultant, Oracle

Ralph Johnson has a degree from the University of Liverpool, where he graduated in 1994. Since then he has worked in various roles within CRO’s, sponsors and software providers, firstly as a data manager and then as a technical data manager. Since 2007 he has worked with Oracle products (both InForm and IRT) at Phase Forward as a design consultant, in industry as the head of electronic data capture (EDC) programming before joining Oracle in 2015 as a pre-sales consultant. He brings a wealth of technical experience in the provisioning and running of the technical aspects of clinical trials.

Who Should Attend?

This webinar will appeal to biotech and small/medium-size drug developers working in oncology and rare disease.

 Key job titles include:

  • Clinical Operations (Manager, Director, Senior Director, VP)
  • Project Management (Director, Senior Director, VP)
  • COO
  • CEO

What You Will Learn

In this session, attendees will: 

  • Learn how to reduce study build times by up to 30 percent, reducing cost while increasing quality, achieving clinical site set-up faster
  • Learn how a cloud platform enables mid-study changes without the need to migrate data  reducing risk and impact on trial success, trial teams, and trial execution
  • Gain insight on how adaptive, lean and flexible operational conduct from a CRO study team enables adaptive data management
  • Review timelines and flexible build process to include challenges experienced and ways to mitigate those challenges
  • Understand how to execute oversight requirements under GCP E2 R2 using online tools
2019-03-13T13:59:09+00:00Events|

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