Holistic Clinical Data Review

Present-day technological advancements have enabled pharmaceutical organizations and CROs alike to collect data from patients in a multitude of methods and this data is normalized, aggregated, archived in a furthermore variety of systems, formats and such – thereby answering a simple question such as “How can I review all of my subject’s safety data?” a highly difficult and operationally challenging to IT, Programmers and everyone involved in the clinical data management operations.
Clinical trial data is reviewed from the day the data is collected and on an ongoing basis for Safety and Drug Efficacy. Answering the aforementioned question becomes critical for the drug development teams every day. Historically the way this data is facilitated varies from an organization to another – anywhere from a network drive holding some datasets in different source formats (such as Excel, SAS® datasets etc…) to an enterprise-scale clinical data warehouse that can take months if not years to conceptualize and implement.
Regardless of however the data is served to the clinical functional user, the traditional ways of file based network drives and warehouses usually tend to add a data latency in bringing the data to the clinical business users such as Drug Safety, Medical monitors, statisticians and programmers.

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1. HUMAN HEALTH • ENVIRONMENTAL HEALTH © 2014 PerkinElmer Holistic Clinical Data Review In near Real-time: Reality or Utopia? Chandi Kodthiwada Product Manager, Clinical Monday, October 19, 2015
2. 2 Safe Harbor This document shows current intentions regarding product features, behavior, schedules and support; these intentions may change without notice as we respond to customer requirements. Any unreleased products, services or features referenced herein are not currently available and may not be delivered on time or at all. Customers who purchase PerkinElmer informatics applications should make their purchase decisions based upon products, features and services that are currently available. It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
3. 3 Our Vision - Principles This document shows current intentions regarding product features, behavior, schedules and support; these intentions may change without notice as we respond to customer requirements. • Out of the box native connectors to source systems ◦ SAS, LSH, Rave, InForm, Argus, Arisg, etc. • Spotfire Templates based on industry standards ◦ SEND, ODM,SDTM, ADaM, CDASH, E2B, etc. • Full suite of implementation services including ◦ Installation ◦ Configuration ◦ Documentation ◦ Testing ◦ Training Leverage experience and best practices to accelerate your success
4. 4 Our Vision This document shows current intentions regarding product features, behavior, schedules and support; these intentions may change without notice as we respond to customer requirements. • Stop working for your data, put your data to work for you. • Maximizing the potential of an Integrated Medical Platform requires moving beyond traditional data storage, management, and reporting techniques. • Right data to the right person at the right time More time making decisions…
5. 5 Sample Clinical Use Cases Data Review Pharmacovigilance & Drug Safety Risk-Based Monitoring Operations It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
6. 6 Typical Clinical Data Review It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations. EDC systems* Excel, CSV etc… SAS Datasets Workstation Source Aggregation Data Enrichment Consumption
7. 7 It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations. EDC systems* Excel, CSV etc.… SAS Datasets Source Consumption Holistic Clinical Data Review - Our Philosophy PerkinElmer’s solution for Smart Connectivity
8. 8 Demo – Connector for Medidata Rave® http://insideinformatics.cambridgesoft.co m/webinars/599/holistic-clinical-data- review-in-realtime-reality-or-utopia It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
9. 9 PerkinElmer’s Connector Framework It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
10. 10 PerkinElmer’s Connector Framework It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
11. 11 Ready. Set. Review… I have the source data – How do I review? • Manual data Extracts • Data aggregation/archival over a network drive, database or a warehouse environment • Typical SAS/SQL programming environments to create SDTM (+/-) It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
12. 12 Demo – Clinical Data Review Spotfire Analysis It is the customer’s responsibility to validate and implement TIBCO Spotfire® software in accordance with their policies and standard operating procedures to ensure compliance with applicable regulations.
13. Thank you! Product Manager, Clinical Chandi Kodthiwada