The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal. For study startup, the data are dismal.
As emphasis shifts towards process optimization, it may be only part of the solution. Point solutions can hinder the flow of data across the continuum, causing already entrenched silos to dig in further. To improve performance quality in study startup, two factors are needed: an end-to-end solution and support from top management.
Unfortunately, entrenched silos such as site identification, clinical development, data management, contracting and regulatory affairs have long stymied these data flow efforts because these departments often have minimal understanding of what is needed downstream.
Speakers
Eldin Rammell, Director, Expert Solutions, Phlexglobal
With over 30 years’ experience in the field of records management, Eldin Rammell’s objective is to help Phlexglobal clients improve working practices, processes and systems through better use of their information assets…. their records! Improvements are achievable through increased efficiency; better regulatory, legal or fiscal compliance; and more effective processes. Records management can be a pivotal factor in achieving these improvements.
Message Presenter
Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences
Elvin Thalund is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies including Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize study startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.
Message PresenterWho Should Attend?
This webinar is applicable to:
- Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
- Sponsor and CRO roles responsible for collecting and evaluating trial metrics
- Sponsor and CRO roles responsible for project management of studies and operational excellence
What You Will Learn
Attendees will learn:
- How automated workflows encourage upfront planning and downstream improvements in the electronic Trial Master File (eTMF)
- Why an upfront emphasis on quality in study startup is essential, including what factors to consider in order to mitigate risk (e.g. Which countries will be used? Which sites/investigators will be used? Which artifacts need to be identified and structured?)
- How the International Conference on Harmonization ICH-GCP E6(R2) guideline defines quality management and builds on the foundation of regulatory documents released by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)
- Why breaking down organizational silos is critical to reducing quality issues
- Why management direction is critical in efforts to jump-start overall performance optimization
Xtalks Partners
Oracle Health Sciences
Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As a leader in Life Sciences technology, Oracle Health Sciences is trusted by 29 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for managing clinical trials and pharmacovigilance around the globe. Learn more at https://www.oracle.com/life-sciences/.
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