DIA EDM and ERS 2014: Working with Regional Affiliates to Achieve Compliance Globally�

At DIA EDM and ERS 2014, there was a lot of discussion around collaboration – between sponsors and CROs, headquarters and affiliates, as well as across global teams. Along with Steve Gens (Gens & Associates), Stacy Tegan (Accenture), and Carrie Mazrillo (Eisai), I presented during the session, “Working with Regional Affiliates to Achieve Compliance Globally.” I was encouraged by the session’s large turnout; the topic had clearly resonated with conference attendees. Steve Gens shared insights from his latest RIM and affiliate industry study, showing how over 30 life sciences companies are prioritizing their technology investments across the regulatory information management (RIM) continuum. He found that areas of collaboration were main targets for improvement – as these are critical to successfully establishing authoritative sources of both information and documents.

Even when sponsors have global systems, information is still commonly duplicated at the local level, and affiliates are spending a significant amount of time in non-value add activities. In fact, from Steve’s survey results, approximately 40% of local time is spent managing regulatory information or taking calls to manage RIM. The question becomes, how can sponsors and affiliates better share information and documents, and trust the information in front of them.

A new approach to technology can certainly help. During my talk I explained that companies must design systems that are accessible, easy-to-use, and flexible for both headquarters and affiliates. Some questions to inform how sponsors define requirements and use cases, and assess off-the-shelf systems, include the following:

• Is this going to eliminate duplicate data entry?
• Will it avoid needing to store a particular document in multiple repositories?
• Will it eliminate (or greatly minimize) requests for status we receive via phone and email?
• How detailed do my information and documents need to be in order to easily find and subsequently reuse them?
• What metrics should I track that will enable me to monitor the health of my operations and ensure compliance with our regulatory requirements and commitments?

Regarding flexibility to support both headquarters and affiliates – it’s a balancing act. Content should be available only to relevant resources (via role-based security, for example) so that global systems can support the superset of requirements while preventing an overwhelming experience for end users.

This ties into a system’s ease-of-use – nothing prevents user adoption more quickly than deploying a system that’s complex and hard to learn. After all, who has taken a two-day class to use Amazon? Both the system navigation and training should be intuitive so that affiliates are not driven to use local tools such as Excel spreadsheets, which are saved onto local network file shares.

The cloud can readily support these design considerations. Its geography-agnostic and device-friendly nature can make it easy for affiliates and sponsors to easily collaborate while cutting down on the number of required local systems. Cloud, therefore, can significantly reduce the IT burden and validation requirements at the local level, where resources are often severely constrained.

The compliance and efficiency-related challenges associated with global growth are really difficult. The importance of seamless headquarters / affiliate interactions has never been more important. The design and implementation of centralized information and document sources which are globally accessible, highly usable, and flexible will be a crucial step in helping sponsors meet both growth and compliance-related goals, alike.

John Lawrie is director, Vault Submissions at Veeva.