Validating cdisc sdtm compliant submission ready clinical datasets

Steven Whittaker, Executive Director, Avoca Quality Consortium, Senior Consultant, The Avoca Group Ellen Kelso, Senior Consultant, The Avoca Group Kristin Mauri, Global Head – Risk Based Monitoring, Bioclinica Dr.

Paul Kippax, Director of Product Management - Morphology Dr.

- The speakers will share insight into how their joint, consultative approach to drug development can help in understanding the absorption and clearance characteristics of a drug substance and how these properties will influence dose prediction and selection of an appropriate formulation strategy - The speaker will share his experiences in developing PCI’s serialization technology platform, along with developing and executing PCI’s strategy for supplying commercial serialized products to domestic and emerging markets across the globe - In this webinar, speakers will demonstrate live the power of real-time clinical data insights and analytics, and what this means for clinical trial conduct and for clinical trial management activities - Viewers will learn how sponsors and CROs that implement clinical payments solutions are benefiting from increased control over study cashflow, improved operational efficiencies, and better compliance cancer pharmacology models, what to consider when choosing the proper model, and how these models are used to investigate combination regimens of multiple immuno-therapies and immunotherapeutics combined with other treatment modalities, which correspond to current clinical investigations Joseph M.

Beechem, Ph D, Senior VP of Research & Development, Nano String Technologies Justin Balko, Pharm D, Ph D,, Assistant Professor of Medicine and Cancer Biology, Vanderbilt University Medical Center - Pharmaceutical manufacturers are scrambling to meet Serialization deadlines, most notably in the USA and EU, and many have already.

Later this year this requirement goes into effect for INDs.

These standards support acquiring, exchanging, submitting, and archiving study data, such as Study Data Tabulation Model (SDTM) for clinical data and Standard Exchange for Nonclinical Data (SEND).

But even when you serialize, the reality of product diversion still exists.

To address this challenge, the FDA has implemented electronic submission guidelines, for NDAs, ANDAs and certain BLAs, using standards developed by the Clinical Data Interchange Standards Consortium (CDISC).

The statement goes on to say that the FDA will publish guidance that “requires study data in conformance to CDISC standards”.

Conversion to CDISC standards generally includes SDTM (Study Data Tabulation Model), ADa M (Analysis Data Model) and CDASH (Clinical Data Acquisition Standards Harmonization).

Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats?

Do you use the American-style month-day-year format or the European-style day-month-year?


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