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How can we help you? |
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“Please allow me to thank the Patni team for the exemplary work you have done in the processing of our subscription work. Your understanding of our processing needs, mapping of the business rules and procedures for our different subscription forms, while re-engineering the process, has been outstanding. Your offshore team was trained successfully to deliver excellent quality within a short period of time. Today, in the face of steep transaction volume growth, your team continues to meet all SLA targets, and its performance has consistently exceeded our expectations..”
Senior Director
One of the largest family welfare
non-profit organizations in the US
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BPO-KPO Service Offerings |
| Life Sciences |
The global pharmaceutical industry is under pressure to reduce drug development cycle time and to meet increasingly tight regulatory compliance requirements in the US, Europe, and developing markets. |
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Patni provides comprehensive end-to-end solution for client’s medical writing, pharmacovigilance and laboratory informatics (LIMS) requirements. Leveraging over 25 years of consulting experience in the Life Sciences industry, we provide a bundled technology and services solution. Working as a strategic business partner, we enable clients to revolutionize their Life Sciences function. |
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Our team of experts includes seasoned physicians, pharmacists, PhDs and healthcare specialists. We work closely with regulatory authorities across the world in the drug safety area. Patni is committed to optimize spend and staffing on quality and safety activities through continuous improvement-oriented service delivery model. |
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Patni’s medical writing services help in ensuring that the documents for regulatory submissions are of the highest quality and comply with applicable regulations. We provide cost effective drug safety services for pro-active pharmacovigilance by utilizing a fully validated, hosted drug safety database from one of the leading vendors. |
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New demands of leveraging laboratory information across the enterprise have also become a challenge. Our Laboratory Information Management Services are designed to help companies address these challenges as they embark on laboratory informatics initiatives. By combining business, technical, and regulatory compliance expertise, Patni's team of professionals can assist in virtually every aspect of laboratory automation - from strategy, planning, and system selection through system implementation, integration, validation, and training. |
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| Key Differentiators |
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Over 23 years of Life Sciences industry experience. |
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Patni’s Global Delivery Model allows low-cost offshore resources for labor intensive tasks with focus on reliability, flexibility and compliance. |
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Reduced cycle times for medical writing and pharmacovigilance activities. |
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Reduced error rates. |
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Patni leverages its skilled medical and safety professionals, along with its highly refined best practices, workflows and SOPs. |
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De-risked migration and operations through structured transition methodology. |
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Software as a Service (SaaS) model for Adverse Event Case Processing. |
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Validated 21 CFR Part 11 compliant process. |
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Experience in Pharmacovigilance with emphasis on risk management, integrated signal detection and evaluation. |
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Experience in clinical trials and drug safety consulting. |
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Significant technical experience in the implementation of market-leading commercial LIMS and Chromatography Data Systems (CDS). |
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| Select Success Stories |
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Patni provided services for writing Safety Specifications of risk management plan for a leading specialty pharmaceutical company. The client needed assistance in developing safety specification of the risk management plan for FDA and EMEA submissions. The safety specification was delivered in a timely manner, enabling the client to proceed with NDA and MAA submissions. |
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Patni provided services for writing Clinical Study Reports (CSRs) for one of the ‘Top 3’ global pharmaceutical companies. The client had a significant number of Phase I and II studies awaiting submission since the CSRs were not written. Patni helped the client to clear the study backlog and line-up future studies for timely submissions. |
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Patni performed knowledge transfer of its best practices in pharmacovigilance services to a Fortune 1000 biopharmaceutical company. The client needed assistance in remodeling their existing practices so as to make them inline with the current industry and regulatory standards. Our team of pharmacovigilance experts, MDs and medical writers customized Patni in-house standard operating procedures, workflows, job descriptions for key roles, relating to pharmacovigilance, as per the client’s requirements. The pharmacovigilance best practices were delivered in a timely manner enabling the client to proceed with their implementation. |
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