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Overview
The pharmaceutical industry continually faces rapid change pressure arising from increased competition, shorter market cycles, drug patent expirations, increasing regulatory oversight, and rising R&D costs. Leveraging IT effectively is now a table stake for pharmaceutical companies to compete in this fast paced environment. IT investment by pharmaceutical companies has become their core strategy for reducing costs, improving revenue and quality, and meeting increasing stringent FDA and other compliance requirements.
Virtusa provides end-to-end software solutions to Fortune 1000 enterprises that address complex, dynamic technical requirements and business needs. Virtusa’s pharmaceutical practice provides specialized services that address the growing information technology needs of companies in the pharmaceutical industry, with the primary aim of making them more agile, efficient and competitive.
We apply our award-winning Platforming approach and Productization® methodology to:
• Improve return on investment for New Drug Applications (NDAs)
• Reduce the cost of managing clinical trials
• Maximize the effectiveness of disparate technologies and systems
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key service offerings for the pharmaceutical industry include: |
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Clinical Trials Management: |
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- Process Analytics & Optimization – We help our clients to:
- Identify constraints, interrelationships and dependencies among disparate processes within clinical trials
- Design corrective action technology and integration solutions to optimize clinical trial processes
- Using our Productization methodology, create a completely integrated platform across all phases of a clinical trials initiative
- Electronic Data Capture (EDC) – Our EDC offering helps clients realize their goals for electronic data capture and data storage. As companies increase their adoption of EDC, Virtusa helps implement an end-to-end solution through process and technology integration
- Trials Management & Reporting
- Patient awareness and acceptance criteria reporting
- Risk information and analysis reporting
- Treatment approach and end-points reporting (dose level administration)
- Toxicity assessment reporting
- Informed consent reporting model
- Uniform performance measurement and reporting
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Sales & Marketing: |
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- Data Integration
- PDMA Requirements – We analyze the entire distribution chain across drugs and identify technology solutions for Sample compliance tracking, documenting and distribution
- Customer Resource Management (CRM) & Sale Force Automation (SFA) Analysis
- We analyze and integrate disparate technology platforms that pharmaceutical companies use to manage multiple drugs
- We are experts in deploying and managing “direct-to-patient” (DTP) marketing technologies
- We provide CRM data analysis and SFA compliance integration solutions
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Regulatory Compliance: |
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Pharmaceutical companies are required to comply with a dizzying array of regulations enforced by authorities across the globe, making the task of regulatory compliance increasingly complex and stressing IT systems in the process. Global pharmaceutical giants need a well-architected regulatory compliance platform to address these requirements efficiently, rather than a patchwork of single-purpose compliance applications. |
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- HIPAA
- Risk assessment and remediation
- Data transmission, encryption and decryption for HIPAA
- Ongoing HIPAA compliance testing for applications
- CSV & Part-11 compliance
- We provide computer systems validation and CFR Part 11 services that deliver reliability, robustness and repeatability in the applications we validate
- Sarbanes-Oxley Compliance (SOX), Corporate Governance and IT Governance
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Process & Data Analytics: |
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Item level serialization in pharmaceutical products is generating exponential growth in data, complicated by lack of data integration. The need to analyze the data from various sources and in multiple dimensions is increasing cost and complexity across the pharmaceutical value `chain. To enable pharmaceutical companies to analyze their data and processes quickly, we provide: |
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- Process & technology optimization across the value chain
- Event and outcome reporting
- CDISC, HLA standards compliance for data integration
- RFID-enabling for drug and equipment tracking
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| We help build products for software vendors that deeply serve the pharmaceutical industry. We are able to leverage industry-leading best practices and trends to help our pharmaceutical clients meet and surpass their business and technology goals. Our product development experience includes: |
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Clinical Trials & Drug Safety – with a leading clinical trials management software company |
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IT Governance, Regulatory Compliance – OpenPages |
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Contract Management and Regulatory Compliance – I-many |
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Document Integrity and Content Management – Vignette, EMC |
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Sales & Marketing – Aprimo, IBM, Oracle |
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| In addition to our pharmaceutical-specific services, our other key services for pharmaceutical companies include: |
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Application Suite Platforming |
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We partner with clients to conceive effective strategies and actionable roadmaps to transform application suites into reusable, flexible and extensible software platforms that are real business assets, and then optimize those assets to provide a strong return on investment. |
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Software Quality Assurance (SQA) |
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We leverage our deep SQA experience to bring innovative process improvements to client project teams and operational support areas, and we help our clients transform and optimize their software quality processes. We focus on helping our clients dramatically reduce the cost of projects by delivering the right SQA rigor at the right time. |
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Application Suite Modernization |
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We offer a full set of services tailored to the large body of legacy applications that pharmaceutical companies typically employ. First, we help our clients assess their current portfolio of applications and conceive the right strategy and architecture to update them. Next, we help transform those applications by executing projects to upgrade and, if needed, port them to the operating systems that best meet the needs of the enterprise, using as needed open source software and internet technology. Finally, we optimize those applications over time through application maintenance and outsourcing using our global delivery model and Productization methodology. |
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| Solutions |
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Process Analytics & Optimization |
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Electronic Data Capture |
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Trials Management & Reporting |
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HIPAA Compliance |
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CSV & Part-11 Compliance |
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Sarbanes-Oxley compliance, Corporate Governance and IT Governance |
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Data Integration |
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CRM/SFA Analysis |
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Process & Technology Optimization |
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Event and outcome reporting |
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CDISC, HLA Standards Compliance |
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RFID Enabling |
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