Hysynth Clinical Development Analytics, Data Migration, Integration, Analytics
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Hysynth Biotechnologies specializes in clinical development analytics (CDA), providing a range of services including pharmacovigilance, data management, and technical support for various life science technologies. Their CDA solution offers interactive dashboards and reporting capabilities to enhance data transparency and operational efficiency in clinical trials. The company ensures compliance with regulatory standards while maintaining high data quality and security through a fully validated infrastructure.
Hysynth Clinical Development Analytics, Data Migration, Integration, Analytics
- 10. HySynth BioTechnologies Clinical Development Analytics (CDA) • CDA is branch of clinical science which is examining raw data with the purpose of drawing conclusions about clinical information • CDA is an extensible repository and reporting solution that supports clinical operation and clinical data management. • CDA includes pre‐packaged interactive dashboards and reports
- 11. HySynth BioTechnologies confidential CDA Benefits • Make better cross functional business decisions ‐ identify risks & mitigate them in timely manner e.g. need of additional trainings for staff at a site, fraud detection, signal detection, protocol deviations. • Greater transparency into the status of a clinical trial subject • Enhanced safety and efficacy monitoring via a holistic review of individual and aggregated subject data • Increased operational efficiency and quality made possible through a transparent and holistic view of data
- 12. HySynth BioTechnologies Scenarios – CRF Workload – Discrepancy workload – How long does a site takes to resolve discrepancies? – On Which CRF page, the no. of Discrepancies are high? – Which procedure generates more discrepancies? – Approval and verification – worst performers – Quality – Patients awaiting first pass, second pass, verification and approval. – Average days for verification and approval. – Processing volumes.
- 13. HySynth BioTechnologies CDA Answers – an ad‐hoc query and analysis tool that processes the data from multiple data sources in a pure web environment. – Users are isolated from data structure complexity and they view and work with a logical view of the information. – Users can create interactive charts, pivot tables, reports, and dashboards. – Analysis can be saved, shared, modified, formatted, or integrated in the user's dashboards.
- 16. HySynth BioTechnologies CDA Products • CDA v1.0 supports data source as OC and RDC. This support only EDC/CDMS • CDA v2.0 supports both CTMS and OC/RDC. • Current version 2.1
- 17. HySynth BioTechnologies CDA Dashboards – CRA Dashboard – Data Manager – EDC Dashboard – Data Manager‐ Paper Dashboard – Study Manager Dashboard – Study Overview Dashboard – Study‐Site Overview Dashboard – Index Dashboard
- 18. HySynth BioTechnologies CDA SECURITY – Study Manager : Access to Index and all dashboards – CRA : Access to Index, Study Overview, Study‐Site Overview and CRA dashboards – Data Manager : Access to Index, Data Manager Paper, Data Manager ‐EDC, Study Overview and Study‐Site Overview dashboards – Project Manager : Access to Index and all dashboards – Admin : Access to all
- 19. HySynth BioTechnologies CDA Reports and Dashboards • Ad ‐ hoc Requests • Filter • Calculations • Data format • Column properties and Condition formatting • Save as new report • Add graphs • Add prompts • Create dashboards and flexibility • Dash board link • Alerts • Direct SQLs • Advanced Tab
- 21. HySynth BioTechnologies Team Strength confidential HySynth personnel are proficient to use a wide range of technologies including ARGUS Safety, Electronic Data Capture, Oracle Clinical, RDC, SAS, TMS, FrameMaker and optical scanning Technical Experts in OC/RDC, Argus, TMS, LSH, DMW, CDA, SAS, Inform, Informatica, Java, PL/SQL, OBIEE, EntimICE, BIP, MDR, Medidata RAVE, Business Objects, JReview, Spotfire, Oracle Ebusiness Suite, Oracle ADF, Forms, OA Framework, DAC and Oracle Database programming and administration. A fully scalable, user friendly, FDA 21 CFR Part 11 compliant clinical data management system Over 100+ employees working in Multiple location and having capacity to expand as per requirement (40000 sq. ft) Department specific SOP’s, Work instructions and work flows
- 22. HySynth BioTechnologies • 21 2U‐Rack mounted servers with tape backup (Dell 2950 with 21 Quad core Zeon processor servers and Raid 5 for Data security) • Business continuity plan/Disaster Recovery procedures • Redundant on‐site/off‐site backup • Information Security Policies and Rigorous IT SOPs • Latest hardware/software (Dell Systems, Cisco powered Networks, Sonic firewall, etc) • UPS, Power backup/Generator facility • 24/7 managed infrastructure by a team of skilled Administrators confidential Infrastructure
- 25. HySynth BioTechnologies Maintenance and Support confidential • Help business for Troubleshooting functional issues • Application maintenance • Administration of OC/RDC/TMS, Argus, Inform, LSH, CDA, DMW and Oracle Database. • Regular health checkups • Applying bug and security Pâtés • Troubleshooting and fixing technical issues With multiple support channels: • Live phone • E‐mail • Remote Access • Knowledge base