HySynth Life Science Technology
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Hysynth Biotechnologies specializes in life science technology, offering services in pharmacovigilance, clinical data management, system integration, and application development. They provide comprehensive solutions including implementation, customization, and hosting of Oracle applications, while ensuring compliance with regulatory standards like 21 CFR Part 11. Their team, equipped with extensive technical expertise, focuses on improving business processes and reducing operational costs for clients in the life sciences sector.
HySynth Life Science Technology
- 6. HySynth BioTechnologies Our end‐to‐end implementation services include Implementation strategy and roadmap Implementation and customize to business requirements Validation, Maintenance and support On the following Life Sciences Oracle applications Argus Safety Suite Oracle Clinical / Remote Data Capture (RDC) /Thesaurus Management System (TMS) Oracle Inform EDC / Central Designer / Central Coding Oracle Life Sciences Data Hub (LSH) Oracle Data Management Workbench (DMW) Oracle Clinical Development Analytics (CDA) Adverse Event Reporting System (AERS) Implementation and Customizations
- 7. HySynth BioTechnologies • Assessment of current IT environment • Application performance analysis and recommendations • Vendor and application selection • Vendor audit • Business case development and cost analysis • Planning IT strategy and roadmap • Requirements and design management • Pilots and proofs of concept • 21 CFR Part 11 guidance • Business process management • Business process reengineering , Best practice analysis and recommendations Consulting
- 10. HySynth BioTechnologies Our team of specialists can help you leverage the benefits of system integration Improved and streamlined business processes Reduction in maintenance and technology costs Elimination of redundant tasks Several integration projects that we completed over the years include: • Oracle LSH with third‐party tools • Custom / homegrown clinical and Safety applications with any other applications. • Oracle Clinical / Simple Forms • Oracle Clinical / Adverse Event Management System (AERS) • Oracle Clinical / Imaging Systems • Oracle Clinical / Interactive Voice Response Systems (IVRS) Data Integration
- 11. HySynth BioTechnologies Our innovative application development process and in‐depth knowledge of the life sciences industry allows you to Meet organizational business objectives and requirements Reduce total cost of ownership Compliance with 21 CFR Part 11 Achieve flexibility and scalability Increase productivity Application Development
- 12. HySynth BioTechnologies Data Migration confidential Data migration we can help your organization, includes • Adverse Event Reporting System (AERS) to Argus Safety • ARISg to Argus Safety • Excel to Argus Safety • Clinical data between Oracle Clinical instances • Any homegrown/legacy system to any Oracle application
- 14. HySynth BioTechnologies Validation confidential • Our validation experts can prepare from Validation plan to Validation summary and help in IQ/OQ and PQ process and documentation. • We also have validation accelerators thru which the documentation process can be speed up and achieve compliance with Computer system validation guidelines and 21 CFR Part 11 guidelines.
- 15. HySynth BioTechnologies Hosting and Managed Services confidential Hosting: We can host your clinical and safety applications in a state‐of‐the‐art data center and provide a comprehensive set of services to manage them. Server and Application Management: We proactively update, back up, monitor, and manage all your servers and applications remotely. Every aspect is monitored and issues can be identified and fixed before they can cause a problem. You can rest assured knowing your data and systems are being monitored and protected 24/7 from our dedicated support team. Application Support / Help Desk: Get quick support by telephone or submit and track a help ticket through the Internet 24 hours a day, 7 days a week via our unique application support system. We can fix most problems remotely, so that you can be back up and running without having to wait for a technician to come to your office. We can help with both application and server issues.
- 16. HySynth BioTechnologies Study Setup confidential We can help you with paper or electronic study setup activities, such as with the initial setup of studies and ongoing support of • Data specifications documents • Annotated CRF/eCRFs • Data management plans and CRF/eCRF completion guidelines • Procedure specifications (e.g., edit checks) • Validation and derivation procedures • Study protocols and study sites • Global library standard objects and procedures • Data extract views
- 18. HySynth BioTechnologies • CDR is used for storing, integrating ,managing and reporting on clinical studies. • It enables pooling of clinical and nonclinical data from multiple sources into a single environment. • Better regulatory compliance with comprehensive security, an audit trail, and traceability • More‐informed decision‐making through pooling and analysis of clinical and nonclinical data • CDR has been developed to revolutionize ability to: • Address complex health authority questions quickly and completely • Produce CDISC compliant submissions • Review safety data in real‐time, mine our overall database for scientific and commercial queries Clinical Data Repository (CDR)
- 19. 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
- 20. 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
- 21. 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