The Great Enabler: How The Cloud Enables Faster Submissions
Market research studies trumpeting the dominance of cloud computing are standard by now. Yet even by today’s hyped-up standards, a new survey by Gartner is astounding. In the research firm’s survey of 2,339 CIOs, 43 percent of respondents predicted that the majority of their IT infrastructure will run on cloud technologies within the next four years. In life sciences, most new data storage, data analytics, and CRM implementations are cloud-based today. And now, pharmaceutical companies are showing greater interest in adopting cloud solutions for submission-related content, according to a recent survey by Gens and Associates. “We have seen a 3X increase in overall investigation of cloud solutions (as measured by product plus pilot plus investigating) since 2011,” states the report.
Several well-known issues are causing the life sciences industry to rethink its approach to managing data and content, including a more tightly regulated landscape and declining pipeline productivity. This in turn is forcing companies to reduce operational costs, go global, and outsource more functional aspects of the business. Companies require the ability to access their content from wherever it resides in the business or externally, quickly and easily. In the face of these needs, developing highly customized on-premise content management systems is labor intensive and inefficient – in stark contrast to the undeniable cost savings and efficiency afforded by cloud technologies.
The cloud is proving to be the great enabler of more efficient, manageable submissions, throughout a drug’s lifecycle. “The cloud technology model supports the key drivers in today’s life sciences industry – global collaboration, efficiency, speed, harmonisation of processes – and it provides the flexibility to scale when utilising contract research organisations or in the case of mergers and acquisitions,” says Rainer Debus, head of client services for global publishing software provider LORENZ Life Sciences Group. Advanced submissions content management systems delivered through the cloud enable:
1. Seamless Global Collaboration allowing internal teams and external parties, including contract research organizations (CROs), to easily access a central repository—anytime, anywhere. This provides a single source of truth so all participants can reliably share documents without having to consolidate hundreds of files. “Today’s teams have to collaborate in real-time on global and regional requirements, which can be supported by cloud-based solutions in a very efficient way,” explained Christian Bohrmann, global vice president for marketing and alliances at Extedo. “Cloud systems integrated with resident publishing tools helps to make these complex processes more efficient from end to end.”
Global organisations today are leveraging the cloud to join dispersed teams around the world. Ipsen Pharmaceuticals recently adopted a cloud-based submissions content management system enterprise-wide, across 20 countries. “The cloud was a prerequisite,” said Malika Mir, Ipsen’s chief information officer. “We wanted one, universal solution that would be easily yet securely accessible by all of our internal and external stakeholders and affiliates worldwide. When it comes to information sharing, accessibility is one the greatest advantages of cloud technology because it naturally fosters efficient collaboration.”
2. Real-time Tracking with ongoing visibility into the status of documents. The cloud provides better visibility into problem-areas and bottlenecks, so the organisation can quickly see areas to improve upon for the future.
3. Improved Affiliate Submissions so local affiliates that may not be fully equipped or linked to corporate’s internal systems can simply access the submissions dossier in the cloud. Affiliate regulatory liaisons can modify Module 1 without changing any other modules and then submit directly to health authorities. At the same time, corporate headquarters maintains ongoing visibility into any changes made after R&D initially hands off the submissions dossier to affiliates.
Collectively, these advantages dramatically speed time to submission, and ultimately, time-to-market. To learn more—and hear directly from leading cloud-based publishing solution experts—read my article in this month’s International Clinical Trials.
Rik van Mol is vice president, R&D at Veeva Europe