Pharmaceutical and Biotech

White Papers


The art of pricing in the pharmaceutical industry

After innovation, smart pricing is the single most important source of competitive advantage for pharmaceutical companies. ...

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...

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 ...

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...

Effective audit hosting strategy – a perspective

Periodic internal and external audits ensure compliance, while diminishing overall risks associated with operations. ...

Best practices in SAP for packing and labeling diagnostics kits

Packing and labeling diagnostics test kits is an intricate part of kit manufacturing. ...

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). ...

Compliance: Towards a unified people, process, and technology compliance framework

Life sciences industry and compliance are like Siamese twins – conjoined and inseparable. Non-compliance to industry regulations could wipe out the industry in totality. The authors ...

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....

HCP public disclosure reporting and compliance – a perspective

The life science industry and healthcare professionals (HCPs) have a symbiotic relationship. Information on patient needs and clinical data provided by HCPs are a guiding force to advance medical research. This white paper outlines the challenges faced by the industry in ensuring HCP spend compliance and explains how a reporting solution can increase reporting efficiency and improve validation and traceability of data changes. ...

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). ...

Leveraging research informatics to accelerate drug discovery

Patent expirations, steep hike in prices, increasing therapeutic needs, and the emergence of biologics for drug development are the ...

Process transformation 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 for business' is evolving into a 'working with business' model. ...

Streamlining drug discovery research by leveraging grid workflow manager

Pharmaceutical companies are under pressure to speed up time-to-market and reduce costs for producing novel drug molecules. This paper discusses how high throughput functional annotation of genomic DNA sequences or profiling groups of protein sequences can leverage grid computing services....

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