Expertise
Leveraging over 25 years of experience in the Life Sciences domain, Patni Life Sciences 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 clients understand the true value of Patni’s high-quality services provided by experienced industry professionals. Patni Life Sciences provides cost-efficient, valued services, regulatory compliance, and advanced application and process capabilities in the life sciences arena.
Domain Expertise
Our long track record of servicing the Life Sciences industry has helped us build deep domain knowledge spanning the breadth of industry areas. With our professional and experienced Life Sciences team, broad suite of enterprise IT offerings, and global delivery model, we annually deliver over 250 projects through our four practices and associated BPO services.
Regulatory Compliance/Quality Management
- Strategic and Tactical IT Compliance
- Computer System Validation (CSV)
- Audits, Assessments & Remediation
- Quality Systems Implementation
- Training and Quality Coaching
- CAPA Process Design & Implementation
- 21 CFR Part 11
- Risk-Based Approach to Compliance
- GxP's.
Enterprise IT
- Applications Management and Support AMS (ERP / MES / CRM)
- Customer Interaction Services (CIS)
- Business Process Outsourcing Services (BPO)
- Verification & Validation of Solutions
- Business Intelligence and Data Warehousing (BI & DW)
- Enterprise Integration
- Infrastructure Management Services (IMS).
Drug Safety and Clinical Solutions
- ADEPT TM AE Case Processing BPO
- Pharmacovigilance Operations Consulting
- Implementation and Validation of Safety and Clinical Solutions
- Medical Writing & Clinical BPO Services
- Drug Safety Signal Analysis
- Strategic Technical Consulting and Application Management Services
- Electronic Common Technical Document (eCTD).
LIMS and Lab Informatics
- Integrated Lab Informatics Strategy
- Selection & Business Case Development
- LIMS Implementation
- ELN Planning and Implementation
- CDS Planning and implementation
- Instrument and System integration
- Support and Maintenance.
Our Key Differentiators
- Providing services to 18 out of the top 20 life science companies
- Deep Life Sciences industry domain experience
- Best-in-class services adopting highest professional standards
- Life Science Industry thought leadership for 25 years
- Continuous monitoring of industry trends and regulatory environment
- Focus on global regulatory compliance
- Qualified and experienced team of Life Science system and validation consultants
- In-house training on Patni methodologies & practices and industry best practices.
Our Delivery Attributes
- State-of-the-art global delivery facilities and technology
- Best-shore delivery team and processes (onshore + offshore)
- Effective methodologies and practices that enable global delivery of high-quality services
- Process and content QC applied throughout the delivery operations
- Practical application of best practices and lessons learned
- Maximum efficiency while minimizing risk, cost, and cycle time.