From manual to electronic: Taking the pain out of the trial master file processes

by William Hamilton Life sciences companies have long struggled with inefficiencies and inconsistencies with their trial master file (TMF) processes. Certainly, manual TMF processes leave many gaps and make it difficult for companies to maintain their clinical documentation sets, but this problem is not exclusive to manual processes. Even companies that have partially or completely […]

A focus on transformation: User group meeting sets sights on the future

By Sharad Khusal, Global Head, Life Sciences Build Team, DXC The message for the life sciences industry is loud and clear: It must manage costs, demonstrate real-world value of its products, and find new ways to innovate and respond to customer demands. It was a discussion that resonated during the Life Sciences User Group meeting […]

LEAN life sciences practices: A macro- and microresponse to document management

By Kim Dyrenius Life sciences companies are under pressure to cut costs and improve efficiencies across every part of the business. For an industry that is data dependent across the research and development (R&D) and the quality and manufacturing (Q&M) life cycles, cost cutting and efficiency have meant adopting LEAN principles when managing documents. Traditionally, […]

User Experience in Regulatory Software

The conversation about systems and solutions for the life sciences industry more often than not focuses on the needs of the enterprise: What infrastructure makes most sense? What configurations do you require? What do the solutions need to enable? But a key consideration needs to be, Is the system simple and efficient for your users? […]

It’s Been a Long Time Coming: On the Path to Eliminating Manual Processes

It’s 2015 and as an industry we’re still struggling with the elimination of manual processes. The attitude in the pharmaceutical industry has always been one of closed systems, with corporate headquarters having access but affiliates and external partners not being allowed into the system. As a result, affiliates and partners were forced to send information […]

Common Sense on IT Projects

By Lena Shafir, Solution Specialist, CSC Life Sciences A few years ago, I worked on a large-scale, multi-vendor project for a pharma company. What struck me about that project was just how well organized and successful it was. Undoubtedly it was expensive, but the real take-home for me was how it stood out as an […]

After a Strong Year for Approvals, It’s Time to Ponder the Changes Driving Innovation

There are articles and blogs in the media about pharmaceutical companies and the drought in innovative products that has hit the industry since 2004, but that certainly wasn’t the case in 2014. On January 14, 2015, Dr. John Jenkins, Director of the Office of New Drugs at the FDA, issued a post that the agency […]