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Health Sciences
March 16, 2020
Dismantling Data Silos to Improve Study Startup and Mitigate Risk
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.
While technology remains critical, as emphasis shifts to 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 they often have minimal understanding of what is needed downstream.
Please join us for this webcast:
Live: Tuesday, March 31, 2020
1pm EDT | 12pm CDT | 10am PDT
On Demand: available after airing until March 31, 2021
This webcast will explore:
- How automated workflows encourage upfront planning and downstream improvements in the 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? etc.)?
- 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 EMA and 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
This webcast 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
Panelists:
ELDIN RAMMELL, Director, Expert Solutions, Phlexglobal
With over 30 years’ experience in the field of records management, Eldin’s objective is to help Phlexglobal clients to 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, more effective processes. Records management can be a pivotal factor in achieving these improvements.
Eldin has been a speaker at conferences including MHRA Symposia, InfoTech Pharma, the Drug Information Association (DIA), ExL-Pharma and IQPC; he has published articles in the GCP Journal and Clinical Researcher. He is Technical Administrator for the TMF Reference Model and Director in the Health Sciences Records & Archives Association (HSRAA).
ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over twenty 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.