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.

In this webinar, featured speakers 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 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

Speakers

Eldin Rammell, Managing Director and Principal Consultant, Rammell Consulting Limited

Eldin has over 17 years industry experience prior to becoming a consultant. In 2003, Eldin left Pfizer as Associate Director of Records Management and established Rammell Consulting to help companies and organizations improve their records management processes.

Eldin has been a speaker at conferences including Records Management Society, MHRA Symposia, InfoTech Pharma, the Drug Information Association (DIA), European Forum for Good Clinical Practice (EFGCP), CBI/Advanstar, ExL-Pharma and Applied Clinical Trials. He has been a guest lecturer at City University, London and has published articles in the GCP Journal and Clinical Researcher. He is an Executive Committee Member and past-President of the Good Clinical Practice Records Managers Association (GCP-RMA) and Director in the Scientific Archivists Group. Learn more at https://rammell-consulting.co.uk/

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Elvin Thalund, Senior Director, Product Strategy, goBalto

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, Hoffman-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in goBalto’s 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.

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