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The Future of Pharma: Challenges and Opportunities of Research and Development, Safety, Regulatory and Compliance Functions

As organizations implement a patient-centric model, they will discover that there is an urgent need to innovate and find effective healthcare solutions. While the Research and Development (R&D) function is becoming complex in terms of portfolio and operations; the Safety, Regulatory, and compliance functions have to increasingly support varied market needs across...

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New Frontiers of Growth in the Life Sciences Industry

The life sciences industry is on the cusp of change. While this change does give rise to some challenges, it throws open doors for new opportunities and possibilities.

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Digital in life sciences: Are you future-ready?

The life sciences industry’s shift to digital has set the stage for connected and smart healthcare. It brings together different players of the industry such as payers, medical device companies, doctors, regulators, and...

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Pharmaceutical serialization track and trace – an easy guide to country-wise mandates

Pharmaceutical companies have to contend with challenges stemming from supply chain security lapses, counterfeiting and stringent regulations. This guide, complied by the Legal and Research team at Infosys...

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Product complaints management – Infosys handbook for life sciences

Product complaint management is critical to the overall market position and brand perception of pharmaceutical companies. There are several approaches to complaint management, the client can choose from – Customer...

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The λ Validation model for regulatory application development

Healthcare applications are largely governed by provisions of regulatory standards such as 21 CFR Part 11. These requirements span through the lifecycle stages of software development.

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The art of pricing in the pharmaceutical industry

After innovation, smart pricing is the single most important source of competitive advantage for pharmaceutical companies. In a world full of smart cards, smartphones, smart money, and smart drugs, whatever happened to smart pricing?

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Contract management in life sciences: Need for an integrated approach

Contract manufacturing organization (CMO) in life sciences has really taken off in the last decade, but it has been around much longer in other industries – like electronics and automotive. Lessons from these industries...

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End-to-end clinical trial supply management with SAP

Efficient management of clinical study supplies across the supply chain, along with precise planning and coordination of activities (both within and outside the organization) – is the key to successfully conducting clinical...

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Master data management for life sciences manufacturers

Master data management is critical to the successful and timely introduction of new products. Life sciences companies need to manage and share master data across a number of departments, including...

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Effective audit hosting strategy – a perspective

Periodic internal and external audits ensure compliance, while diminishing overall risks associated with operations. They help identify potential issues, implement contingency plans, and manage solutions before...

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Enterprise mobility with Sybase Unwired platform

Many organizations face the need to make an important decision of choosing the right development approach after selecting a mobile platform like Sybase Unwired Platform (SUP). While there is no best solution that works...

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The λ validation model for regulatory application development

Healthcare applications are largely governed by provisions of regulatory standards such as 21 CFR Part 11. These requirements span through the lifecycle stages of software development. This paper examines the current limitations of using the V-model for regulatory application development and proposes an improved model to reduce time and cost of qualifications....

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Information security challenges in a shared services model

While the financial upside is encouraging, the pitfalls of IT security are a significant deterrent in adopting the shared services model (SSM). With the right amount of focus on IT security governance, adequate...

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Process reinvention for better IT service delivery in the pharmaceutical industry

Soaring drug development costs, patent expiration, and reduction in the number of blockbuster drugs are driving pharma companies to look at IT-enabled productivity. The traditional approach of 'working...

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