Simplifying Clinical Data Flow from EDC to SDTM

Do you want to have better clinical trial oversight, faster study execution and improve study quality? Join this webinar to learn 5 lessons to master clinical data aggregation, transformation, cleaning and analytics to reduce cost, risk and time.

Recent trends in clinical trials – including the increasing availability of clinical, operational and real world data streams – offer the opportunity to gain better insight over clinical R&D as never before, but poses interesting challenges with data aggregation, harmonization and collaboration. To take advantage of growing clinical data streams requires new capabilities to automate electronic data capture (EDC), clinical data management and operational analytics business processes using simplified technology platforms.

Today, taking clinical trial data from EDC to Study Data Tabulation Model (SDTM) is time consuming, resource intensive and complex. More often than desired, clinical data resides in silos across study teams, data management groups, statistical analysis and clinical operations. This makes optimizing clinical data flow challenging, if not impossible, and creates operational inefficiencies that will simply not scale to meet the needs of key business stakeholders planning for the future.

The good news is that there are innovative ways to overcome this complex challenge.

Speakers

Srinivas Karri, Senior Director of Strategy, Global Business Unit, Oracle Health Sciences

Srinivas Karri is a Senior Director of Strategy at the Oracle Health Sciences Global Business Unit. He is responsible for clinical platforms and applications used by clinical trial sponsors to collect, manage and use clinical data as part of the clinical drug development process. Prior to working at Oracle, he was responsible for clinical applications at F. Hoffman La Roche managing and operating a variety of validated applications used by global clinical operations. He has over 17 years’experience in the field of validation systems, clinical applications and pharmaceutical drug development and manufacturing in a variety of global roles. He has a degree in Chemical Engineering and an MSc in Process Systems Engineering from Imperial College, London.

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Maria Perkinson, Director, Kinapse (a Syneos Health company)

Maria brings more than 20 years of experience delivering business and IT transformation solutions. She has extensive experience in clinical trial operations and management and is an expert in applying program management, process improvement, innovation and change management methodologies. Maria has led many large-scale, global initiatives within the pharmaceutical industry that include process optimisation and technology improvements, driving operational efficiencies. Her technical experience, background in analytics and process improvement coupled with her ability to bridge disparate organisations and disciplines brings critical value as technology and innovation play an increasingly important role.

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