Why Life Sciences Companies Are Moving from Transactional to Strategic Partnerships

The nature of the partnership between life sciences companies and regulatory process providers has changed significantly over the past decade, moving steadily away from one-and-done deals to long-term relationships.

The advent of electronic Common Technical Document (eCTD) in 2002 resulted in sponsors seeking support from vendors as they struggled with such a new concept. For an industry that was accustomed to paper submissions, electronic was both familiar and complex, requiring expertise in the XML backbone. And as the regulatory authorities steadily moved toward mandating eCTD, the scramble was on to find outsourcing partners to take on the burden.

But those relationships were typically transactional, driven by a problem that sponsors generally would “throw over the wall” to vendors. There was very little collaboration. The sponsor did its part, while the vendor carried out specific tasks.

The problem with such relationships is that they offer little incentive for either party to build a rapport, to look for ways to improve processes or find long-term solutions.

Investing in the long term

What we’re seeing more and more now is that companies want a longer-term, trusted relationship with their vendor partner. They seek out partners that can take on a deeper, more complex range of projects and that have proven quality metrics with regulatory submissions.

What separates a strategic partnership from a transactional one is the level of commitment involved. With a strategic relationship, there’s investment in building value on both sides. It’s about investing time in the relationship, since typically such relationships extend for more than two years. Each side is committed to developing better business processes and workflows that help align the way both the client and the vendor works. With a strategic partnership, it’s never “they and us,” but rather bringing resources together to achieve goals and milestones.

There’s no doubt that a strategic relationship will cost more up front than a transactional one, so it’s important to assess the value to the organization and the longer-term return on investment. First, there’s the question of how best to deploy your resources. Today, eCTD is fully entrenched in the regulatory cycle, and more and more global regulatory authorities are moving in the direction of electronic. Is it worth a major infrastructure investment on the operations side to handle the whole electronic publishing operation in-house, or does it make greater sense to have existing internal resources focus on more strategic projects?

Choosing a strategic partner means that the vendor becomes an extension of your own operations, without the additional costs associated with having full-time employees — salary, benefits, training and so on.

The bigger, most experienced vendors also have offshore resources to draw on, which not only means greater cost savings for clients, but also allows them to tap into a follow-the-sun model and complete submissions more rapidly and thoroughly.

Establishing expectations

While strategic relationships confer greater value, they also require more up-front thought and commitment. It’s important to establish proper SLAs and to build strong governance models and work processes, because essentially what you’re doing is creating a single working group.

Communication is key, as are trust and transparency on both sides. Stakeholders from the vendor and sponsor need to have regular discussions and be open to change, for example, adjusting standard operating procedures and best practices according to what works best for the partnership. Both parties need to work together to mitigate any potential problems and be aware that in any relationship issues will arise; the key is to figure out ways to work through them together.

There will also inevitably be concerns on both sides. From the sponsor side, concerns arise over loss of control and fears over who is handling your data. It’s important to know that your partner has your processes and submissions under proper control. Our point of view is: To do that, the vendor needs to use full-time employees — as opposed to contractors — to ensure that control and transparency.

Other concerns relate to opening a secure environment to an external partner. That’s a necessity when it comes to managing regulatory submissions, but it demonstrates why transparency and trust are so crucial.

Many factors go into building a strong, enduring and trusted partnership, and one of those is the day-to-day relationship the client has with its partner, through a project or program manager. In my next blog, I will explore the role of the program manager in more depth.

Learn more about DXC’s regulatory expertise and our commitment to long-term, transparent relationships.


Leslie Wan is global head of DXC’s Regulatory Engagement Management group.

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  1. […] my last blog, I addressed the move from transactional to strategic partnerships. I’d like to address a key […]

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