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.
Join this free webinar to review strategies for data management in modular and adaptive clinical trials.
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 Ltd
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
Message Presenter
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.
Message PresenterWho 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
Xtalks Partners
Simbec-Orion
Simbec-Orion Group is a full-service Boutique international CRO. Focused on oncology, rare disease and healthy volunteer studies. We offer our clients a full spectrum of drug development services from first-in-human Phase I clinical studies through to pivotal Phase III studies and Phase IV post-marketing studies. We have expertise in all drug types, dosage forms and delivery mechanisms. Established in 1976 our experience and expertise enables us to become a true ally on your drug development journey
Oracle
Oracle offers a comprehensive and fully integrated stack of cloud applications and platform services. For more information about Oracle (NYSE:ORCL), visit www.oracle.com.
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