Life Sciences
Infosys offers an array of services for Pharmaceutical and Life Sciences companies leveraging Oracle’s Health Sciences Global Business Unit (HSGBU) suite of applications. We provide end-to-end solutions that cater to clinical research and data management needs. Our disparate team of functional and technical professionals aid Pharmaceutical and Life Sciences companies through the entire lifecycle - from protocol design to regulatory submissions, including data management related activities.
We service four of the top five Life Sciences companies worldwide and our credentials in the domain include:
- Development and maintenance support to 'Siebel - eClinical' based post marketing pharmaco-surveillance application
- 17x5 Oracle Clinical Application Support, Regulatory Compliance services, 21 CFR Part 11 Compliance L2 Support, and Processes documentation
- Global support to Oracle Argus
- Maintenance and enhancement support for 'Clinical Trial Relationship Management' system
- Re-engineering of pharmacovigilance system
- Implementation of Oracle Clinical (OC) in eight Life Sciences firms
- Solution development for E2B interfacing between Adverse Event Management forms from different clinical trial sites and Argus Safety
- Enrichment of Clinical Trip Reports and Clinical Supplies Management Reports in Siebel eClinical and Actuate applications
Services:
Our services include selection of suitable applications that match the company’s needs, customization of standard applications, implementation, support, and application up-gradation. We ensure utmost compliance with regulatory requirements, company’s standard operating procedures, protocols, and other processes and practices.
We offer requirement based installation, implementation, customization, and up-gradation support for the following applications:
- Applications in Clinical Data Management Systems (CDMS): Oracle ClinTrial, Oracle Clinical and Oracle LabPas
- Applications for Electronic Data Capture (EDC): Oracle Clinical-Remote Data Capture (RDC), Oracle-Inform
- Applications for Safety Data Management: Oracle Argus, Oracle Adverse Event Reporting System (AERS)
- Applications for Data Warehousing and Analysis: Oracle’s Life Sciences Data Hub (LSH), Oracle Clinical Data Analytics (CDA), Oracle-Clinical Development Center (CDC)
- Seibel Clinical Trial Management System (CTMS): Maintenance of site and personnel information, generation of CRA visit reports, and issues management
Demonstrable proof-of-concepts on Oracle Life Science Data Hub (LSH) at our Center of Excellence Lab:
- Integration of disparate data sources
- Standardization of data for easy reporting
- Generation of CDISC outputs for regulatory submission
- Generation of Signal Detection reports on Pharmacovigilance data
- Generation of Clinical Trial dashboard reports
- Automation of Workflow to improve R&D productivity
Highlights of our Argus capabilities at our Center of Excellence Lab:
- Data migration following 21 CFR Part 11 compliance
- Data reconciliation and case processing
- Data mining services on Pharmacovigilance data
- Implementation of E2B interfacing
- Integration of Argus Insight with SAS reporting tool
- Multilingual support services for multiple locations across globe
Highlights of our Oracle OC, RDC, AERS, and Thesaurus Management System (TMS) capabilities:
- Accelerated deployment of Oracle Clinical-Classical, RDC, Oracle Clintrial, and InForm GTM
- Integration of InForm GTM with other systems
- Validation services to ensure 21 CFR part 11 compliance of existing environments, SOPs and processes
- Central coding and TMS Dictionary loading, upgrading and domain configuration
- Application upgrade and support for existing environments on all platforms
- End-to-end configuration - from setting up protocol, designing clinical database to data extraction for OC, RDC and AERS
- 24x7 multilingual, multi-site support
Co-development with Oracle
Clinical Trial Payments for Siebel eClinical (CTMS-PIP) solution:
- CTMS PIP solution offers pre-built web services/ integration capability to enable complete investigator/ site payments process flow
- PIP enabled through Oracle’s Fusion Middleware Application Integration Architecture is configurable and extensible
- Partial PIP approach offers flexibility to refine and route messages to as many intermediary or target financial systems as required
- Assists in achieving timely payments to investigators thereby enhancing and improving relationships with key stakeholders
- Integrates with any financial system: SAP, LAWSON