What life sciences companies stand to gain from integrating regulatory content management and publishing

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By Sadia Ahmed Life sciences companies are increasingly looking for better integration and interoperability across their various content management systems and improved oversight of regulatory content to address both compliance and efficiency demands. This is particularly important for regulatory publishing amid a push to improve both data quality and processes. While a content management system […]

Doing more with less puts automation at the center of the submission process

By Sadia Ahmed and Marcy Miller The days of throwing money into research without clear objectives and goals for getting to market are gone for most life sciences companies. Today, the pressure is on to cut costs and to find ways to bring drugs to market — and to the patients who need them — […]

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, […]

The Importance of Biometrics in a Regulatory Submission

Changing regulations and new requirements about how data needs to be gathered and presented in a submission is creating challenges for life sciences companies, and in particular for smaller companies that simply don’t have the resources to keep up with the requirements. By Mark Tumelty, Manager Biometrics and CDISC, Life Sciences, CSC As I mentioned […]