Global Alignment with Local Affiliates

Q: Steve, according to your 2013 RIM benchmark, 46% of respondents are actively consolidating systems. That seems like a high number. Is that a consistent ongoing process within organizations or has something recent motivated or enabled this consolidation?

A: This drive for harmonization has been building for years, although it’s picked up speed in recent years with growing globalization on the clinical and commercial sides. In 2009, a number of companies started implementing large global product registrations. As part of that process they analyzed the local requirements, including where local affiliates store their information, whether in Excel, or in a home-grown system.

With these big, big global systems, people learned that if you can’t accommodate “all” the local requirements within the global systems, the local affiliate cannot retire their local tool. They will be working in multiple systems: both the local and now the mandatory global solution. Some affiliates using just Excel spreadsheets, with limited tracking of registration and submission planning data, can easily consolidate into the global system. However, affiliates with more extensive local requirements usually end up running their process in parallel for some time. Finally, some local affiliates just don’t want to retire their local systems and end up working in two applications, thus adding to the administrative burden at the local level.

Q: Your 2013 RIM benchmark also shows that 49% of respondents are improving access and information exchange for affiliates and regional offices. What are the primary initiatives or tactics that sponsors are using to improve affiliate access and information exchange?

A: Some sponsors opt to grant affiliates direct access to the global system. Often affiliates get full access to the native application, even if they’re only using a very, very small subset of the functionality. They become overwhelmed with the complexity. What works for the daily user doesn’t work for casual users, like the affiliates.

Some companies are investing in portals or limited data entry screens to make it easier for the local person. A portal could give access to multiple systems from one place; or it could manage basic transactions and communicate changes back to the native application. Some affiliates use a web form instead of going directly into the system. So there are a variety of techniques, but I think the fact that 49% of respondents report making changes to improve information sharing is significant; people are really seeing the need for a single source of truth.

Q: Thanks, Steve. You say that the administrative burden on affiliates is increasing and that relief is needed. What are you recommending to clients wanting to reduce that administrative burden?

A: Reducing administrative overhead is a huge driver in the push to consolidate systems. If people at the local level update the status for a label change in the global system and in their Excel spreadsheets, that’s double effort for every change. Affiliates also get a lot of calls and emails regarding the status of their local products. The survey results showed about 10% of Affiliates’ time is spent answering basic questions about registration and label status. You could save two to four hours per week if a global authoritative source for regulatory information were truly trusted.

There are a lot of ways to make this a reality. One critical point is system usability. Having an interface that a casual user can use to input their data into the system directly would dramatically reduce the overhead. Another aspect is better education and training. There could be new people in the local office, or existing folks that don’t know the global system well enough. A lot of companies have long archaic training manuals as opposed to short videos that users can access when needed.

The last thing is data governance, which is a struggle for global systems. Having some formal structures, processes, and reports around the quality of the information will improve its reliability, which reduces the need to call or email the original source.

All these pieces add up to significant time and cost savings for the sponsor and the local affiliate – streamlining processes with a global system, addressing local requirements so affiliates can relinquish their application, and providing easy on-demand training.

Q: Steve, I’d like to thank you for your time. Do you have any parting words for our readers?

A: Only a reminder that headquarters or regional offices should use the current sources of information first, as opposed to just calling or surveying the local office. Simply becoming a little more self-sufficient would reduce the administrative burden at the local level.