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, that you know the right questions to ask when speaking to service providers, and that you have a clearer perspective on the benefits of partnering.
By Jennifer Tucker, Regulatory Affairs Manager, Business Process Services, CSC
Understanding the Barriers
One of the biggest concerns companies have with a BPS engagement is maintaining control. The worry is that you may lose control over processes and your documents once you hand them on to a third party. Is your information secure, are there defined workflows in place, and can you be sure data won’t get lost in the shuffle?
A second issue for companies involves people. For years, heavy use of traditional in-house operating models has meant that internal teams are accustomed to handing off a project to a person just down the hallway. But with BPS and its emphasis on remote resourcing, there’s a sense that you’re losing that in-person interaction, which can be further compounded when off-shore resources are introduced.
There are additional people-related concerns surrounding the quality of BPS personnel coming into the project. Will you have the opportunity to vet BPS team members? How can you be sure they have the right combination of skills and experience? And maybe most importantly, how accessible will they be? Will you be able to be able to get in touch when you need to and how will that communication happen?
Perhaps unsurprisingly, the final concern is cost. Those new to a BPS engagement sometimes question the fees relative to the costs associated with in-house employees and technology/tools. Keeping everything in-house may seem cheaper at first glance, but there are a lot of expenses that you save when you hire someone, such as benefits, infrastructure and other indirect costs. An apples-to-apples comparison shows that using a service provider can save a lot of money on your critical, but non-core processes like regulatory submissions. Tied to cost is the question of value for money – the importance of knowing up-front that what you’re getting brings greater benefits than managing everything internally.
What You Need to Ask
To ensure your concerns are heard and addressed as you begin assessing BPS partners, it’s important to ask pertinent questions that will help you determine what and who will work best for your company.
Starting with concerns around control, you’ll want to ask how the quality of your documents will be managed – overall and throughout each submission. What assurance can your provider offer about security of the document management process? Will you be able to track and review submissions throughout the process to be assured of quality every step of the way? And who will take the lead to make sure problems don’t fall through cracks?
Our advice when it comes to vendor-client communication is that there should always be a dedicated point person from the provider and from the client. Having a one-to-one relationship is far more efficient than having too many people involved in back-and-forth discussions.
You should also ask any potential partner for metrics regarding things like number of submissions they have handled, types of submissions, global experience and error rates. They should also be able to provide metrics related to real cost savings that other clients have reported when using a BPS partner versus maintaining those activities in-house. These will tell you a lot about the service provider and their expertise.
Seeing BPS Outcomes
In a good BPS engagement, there should always be demonstrable benefits that counter potential concerns.
On the issue of cost, eliminating nearly all of the IT costs associated with regulatory submissions is a huge advantage for companies. Many companies have reported savings of 20% to 30% over what they were paying to maintain those submissions processes and personnel in-house.
Agile workload management is another benefit, since BPS can allow you to leverage off-shore resources that can vastly expand existing capabilities by supporting submissions activities up to 24 hours a day, 6 days a week. The fact is, there are very few life sciences companies that could manage that sort of operating model on a long-term basis.
In addition, you eliminate a lot of overhead required for managing personnel training and costs associated with attrition – in other words, the high expense involved when people leave and you have to train new staff.
As my colleague Leslie Wan discussed in her blog, flexibility is another important benefit. With a BPS partner, your resources are project-based, meaning you have capable, trained resources that can be brought in as and when needed, but who aren’t a cost when they’re not working for you.
Having a team of experienced people who are focused on a specific activity every day, rather than being pulled onto other types of activities as would happen in-house, provides assurance of knowledge and skill level.
In addition, when you’re working with a BPS partner, you’re not only getting the expertise of the person or team that’s assigned to you. That partner will have a whole team of BPS experts that provide industry perspective and best practices. As a result, you gain the power of those collective resources across all your projects.
Learn more about the BPS journey and what it can mean for you by listening to the recorded DIA and CSC webinar, Business Process Services – Strategic Enabler for Quality Regulatory Submissions.