Life science companies are facing a growing number of business and regulatory pressures fuelling the need for business transformation. Patent expiration, mergers & acquisitions, organizational restructuring, downsizing, and budget cuts are clear indicators that change is constant. Moreover, electronic medical records, and a more conservative approach to patient safety and drug/device approvals is rapidly changing the way life science companies do business.

iGATE’s Life sciences practice leverages its combined strengths in FDA compliance, IT and domain expertise, to provide business transforming consulting services and solutions to the life sciences industry. With our unique business model of integrated IT and operations (iTOPS), our high-end services tailored to the life sciences value chain, and our three decades of life sciences experience, we help our clients manage key industry challenges like:

• Breaking down data silos, improving collaboration during clinical trial management and enabling improved time-to-market.
• Monitoring business performance / Ensuring cost-effectiveness of safety operations
• Increasing FDA and global compliance requirements
• Cost Transformation / Operational Improvement
• Turning around inefficient and ineffective management of acquisitions, alliances, partnerships, and licensing.

How iGATE can help you
Leveraging over 25 years of experience in the Life Sciences domain, iGATE Life Sciences practice is well-qualified to effectively manage a regulated IT environment and help your company meet its quality, systems, regulatory, business, and organizational goals. We have been intimately involved with our clients helping them create harmonized, risk-based, and cost effective IT organizations compliant with both domestic and foreign regulatory requirements.

Our core Life Science service offerings include business transformation solutions providing lower costs and enhanced service through improved governance & compliance, technology integration, and collaboration with partners. Our market leading outcomes based relationship model includes an integrated IT and operations (iTOPS) service model specifically tailored for pharmaceutical, medical device, biotechnology and clinical research organizations.

Business Transformation Services: We offer strategic planning services to develop global vision for future business operations along with business process improvement and business case analysis services through our modeling and simulation frameworks. The strategic services are coupled with end-to-end business and technology services.

Research Accelerator: Our Research Accelerator for R&D provides clients an innovative architecture for accelerating the drug development lifecycle while rationalizing the IT portfolio. The solution consists of a pre-configured hosted platform of the Oracle Health Sciences suite of products together with an outsourced services component. The Research Accelerator solution is designed to provide pharmaceutical companies access to a low-cost operating model with next-generation technologies.

Pharmacovigilance Solutions: We offer a comprehensive set of drug safety products and services — Intelligent Solutions-PV™, which helps clients to improve processes, procedures, signaling capabilities, documentation, and proactive monitoring. Intelligent Solutions-PV™ facilitates compliance with Good Pharmacovigilance Practices (GPVP). The PV services span across consulting for risk management plans, system implementation, validation, business process outsourcing for medical writing and adverse event case processing.

Quality and Regulatory Compliance: We have an established track record supporting clients in the development of quality system policies and guidelines, regulatory interpretation, and the selection and implementation of enterprise IT systems that help support quality control testing of raw materials, in-process and finished goods.  We work with clients across the regulatory spectrum to build integrated compliance philosophy for Regulations including but not limited to Sarbanes-Oxley (SOX), Health Insurance Portability and Accountability Act (HIPAA), 21 CFR Part 11, and GxPs.  We are an implementation for many vendors and we have an SAP certified solution specifically designed to address CAPA and complaints management.

Computer Systems Validation: We offer risk management and regulatory compliance efforts conforming to GxPs and 21 CFR Part 11 as integral components to our clients’ computer system validation approach. Our managed CSV center approach with lean compliance and risk based principles help to reduce the overall cost of compliance.

Manufacturing and Supply Chain Solutions: We offer a gamut of services from supply chain consulting to packaged application implementation and validation. We also offer assessment, planning of manufacturing execution systems and associated control systems. Our inventory risk liability dashboard and clear-to-build solutions on top of SAP platform help customers in managing inventory aspects.

Life Science Analytics: Our differentiated Business Intelligence solutions like clinical dashboard, Pharmacovigilance dashboard, Signal Intelligence PV™; annual product review reports and sales analytics provide decision support across the life sciences value chain.

Product Engineering: Our product engineering group has extensive expertise in undertaking end-to-end product development right from Mechanical Design, Electronic System Design & Development and Application Development and all associated phases of regulatory document preparation. The business unit has been associated with over 25 world-leading product OEM(s), Tier-1 vendors and product companies across multiple domains in Medical devices and Healthcare. iGATE has also expertise in Clinical Validation of the products.

Track Record for Client Success
Some of our representative engagements include:

• Adverse Events Case Processing KPO service, for a pharmaceutical major
• Sales and Marketing Analytics, for a major medical device manufacturer
• Global ERP implementation, for a major medical device manufacturer
• Compliance Remediation Program, for a large medical equipments major and pharmaceutical major
• Business Process Improvement for supply chain, manufacturing, sales processes for a tissue cell manufacturer
• Complaints management solution, for a medical supplies customer
• Quality Systems consulting, for a pharmaceutical major
• Mobility solution for Sales force automation for a pharmaceutical major.