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 […]

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, […]

Unravelling Concerns: Why a BPS Engagement Makes Sense

More and more life sciences companies are gaining value over the long and short term by outsourcing their regulatory submission activities. However, the decision to bring in a business process services (BPS) provider can still be a difficult one to make. At the outset, it’s important that your concerns surrounding a BPS engagement are understood, […]