PatientCentric RD Networked Collaboration Diagnostics Info Genomic Info
Patient-Centric R&D – Networked Collaboration Diagnostics Info Genomic Info Imaging Info Target Tracker Anonymization / ETL Standards The “Cloud” Alerts HL 7 CDA CDISC/ ODM IMAGE-ML BSML Hap. Map Curation Curated Information Repostitories Storage Virtualization Computational Virtualization Clinical Samples In-Vivo Assays In-Vivo Models Translational Genomics Multi Gene & Protein Profiling Genetic & Epigenetic Events Biomarkers Saa. S Sequence Visualization Patient-Centric Research Informatics Platform Dashboards Chem. Structure Collaboration Portals ISB, NIH, Mayo Clinic, Moffitt, UCSF Biobanks Cell Lines Assays Analytics PDB Assays PK/PD Derwent Plasmid Reagents ACD Transgenic Compounds Public / Private Libraries Pre-Clinical Research Computational Biology Clinical Research Systems Biology Modeling/Simulation Cheminformatics LIMS
Portal / Doc. Base – Business Process Flows Project Team Leaders Role Designation Team Meetings Metrics? Team Meeting Prep Scientists External Access IS Support Management Reporting Content Sharing & Re-Use Input Content Scientist Super User Progress Management Content Submission Rules Access & Permissions Setup & Admin Search Content Team Calendar Content “Pruning” Folder Creation Conduct Training Technical Problem Resolution Content Archival Metrics System Upgrades Team Leadership Scientists External Users Scientist Super User IS Support
Portal / Doc. Base – System Schematic Requirements TGI PCC Tracker Chem Kart Target Tracker BI Tools Setup Access & Permissions Scientist Decision Project Team Meeting Prep e-Mail Interface Management Reporting Project Team Meeting Integration into Doc. Base Instrument Generated Data Content Deletion Data/Info Search Content Archive Content Maintenance Alerts Innovative Data Use Alerts Data Re-Use Doc. Base Key Rules Inputs Uses Access By Other DB’s
Product Flow Manufacturing 1 Primary Distribution Channel Intermediaries Inventory Site Dispensing Authorization for Inventory Release Infusion Sites E-Co 1 BIIB Bio Direct Infusion Site Medicine Direct Infusion Site 2 3 Medicine Direct Specialty Pharmacies Infusion Site Medicine Direct Hospital Pharmacies Hospital Infusion Site 4 Nova 5 6 Infusion Site
Integration Project “Touch Points” between Sarbanes and FDA Scope and Plan System Requirements Development Teams FDA Requirements Sarbanes 404 Blue Print Realization Design & Configuration Implement Beta Testing GXP Requirements IQ, OQ, PQ Development Validation Testing Internal Control Requirements Internal Control Documentation Internal Control Testing 1 Identify & Track Mutual FDA and Sarbanes 404 Requirements 2 Coordinate Control Documentation Activities for Mutual Requirements 3 Implementation Validated State Implementation Rationalize Testing Where Possible
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