Global Content Management Supporting Better Submissions Management: Veeva R&D Summit Insights

At Veeva R&D Summit 2014, customers and experts outlined best practices for creating a single, global source of truth to enable better submissions content management. Here are the top takeaways for improving processes across the enterprise, the affiliate network, and with partners:

Joining Groups Across the Organization

Global pharma Ipsen shared insights on re-engineering content planning by standardizing on a single cloud-based content management system. Ipsen outlined its approach to planning and tracking submission content, describing how its move from legacy to an open, collaborative system is allowing it to work more effectively while maintaining compliance.

Similarly, Deloitte presented best practices for mastering the regulatory content challenge. Noting that submissions quality has a direct impact on time to market, Deloitte gave tips on sharing content and data more effectively across clinical, quality, and regulatory teams.

Streamlining processes by improving the visibility of content status across the organization was a key topic for another Vault customer.  Their regulatory operations can now better manage the thousands of documents in a marketing application, and report to senior management regarding progress across all R&D areas.

Solving the Affiliate Challenge

Industry expert Steve Gens discussed preliminary results from his RIM and affiliate benchmark study, emphasizing that corporate-to-affiliate communications are currently fragmented and inefficient. The study reveals 40% of affiliate time is spent managing and communicating regulatory information with approximately 25% of overall time being spent on “non-value” activities such as having to re-enter information and take inquiries because confidence in the quality of information stored in global systems is low. Ninety-one percent of survey respondents stressed that usability is a critical area needed for greater uptake of global systems. The highest-ranked benefits from cloud technology include increased flexibility, faster implementation, reduction in cost, and improved access – all key needs to improve headquarters / affiliate interactions.

A New Wave of CRO Innovation

Covance’s session demonstrated that sponsors aren’t alone in upgrading their content authoring and management systems to improve collaboration. As the CRO marketplace continues its rapid expansion, those CROs that can work more efficiently and collaboratively will distinguish themselves from their peers – and more effectively meet customers’ needs. Covance discussed how their new content management platform will be the foundational piece for expanding the breadth and depth of their regulatory-related services.

I was honored to take part in some critical conversations about transforming regulatory content management strategies and hear real-world examples from companies doing just that. To get more expert advice on process harmonization and submissions content management, check out this webinar on improving compliance and efficiency when working with regional affiliates.