OUTSOURCING
What are the key challenges in procurement contract negotiation? Timelines are always an issue – everything needs to be done today or yesterday, and folks generally don’t get the contracting process. They have listed everything they need us to do, but there is a language that needs to be used, terms that need to be considered.
When it comes to budget, we have to reconcile for clinical finance. Has this been budgeted for? Can we get it approved? Is this fair based on fair market value, or based on industry standards? Then the approval process is an issue as these things go up to the C-suite.
Other challenges are getting people to understand that clinical operations is a centre. Then there are the deliverables, making sure contracts are being adhered to, and stepping in when there is an issue, like around personal conflict in project teams.
What are you best practices for conflict resolution and issue management? Usually, the project teams will take a first pass. If it is around money or legal, I say pass it to me. The project teams generally have to work together on a day-to-day basis, and if there is an issue, we can shake things up, and the folks on those teams don’t remember us, so the role is not to impair the day-to-day working relationship with the sponsor and the vendor. We’re not there at the front end. When there is an escalation to me, I ask: “What did the vendor do?” The sponsor, my folks, will say they told them what they needed, but it’s not always clear cut.
How has the pandemic affected your work, and do you think vendor relations have changed? I would say we were probably busier. Mid-point during the pandemic, there was a rush to get amendments like clinical trial agreements (CTAs) done because sites were shut down. The second thing we saw was the influx of
“The project teams generally have to work together on a day-to-day basis, and if there is an issue, we can shake things up.”
28 | Clinical Trial Supply Handbook
amendments around COVID-19-related services and issues, and I have filled in a lot of COVID- related costs. When it comes from a site, I understand there are COVID-related safety protocols, whereas from a vendor, it’s vague. After that, it levelled out. I often think how much easier it would be to negotiate goods as opposed to services.
How do you create a robust specification on the scope of work you expect from a partner? Usually, our RFP (request for proposal) will lay out the specifications based on the protocol. From the proposal, the vendors will respond and put together a scope of work based on sponsor requirements, and that begins to form the contract. The internal review process is critical: meeting with the trial manager and various functional leads to review, question and compile comments to budget or contract, and returning to the vendor until we have a scope and budget that we can agree upon.
Do you have any examples of challenges or issues you’ve experienced with vendors? I’m working with a vendor that requires bits of information that my company may not be able to, or feel comfortable, providing. That means we have to work with various teams to determine the best way forward. General pain points would be when vendors
don’t adhere to our timelines or behave as if they don’t know what our timelines are. Another is resources. It’s great to meet the team assigned to your project during bid defence. It provides an opportunity to assess the synergy of the team and their understanding of your project. Sometimes, depending on the passage of time between the bid defence and the start of the project, you may not have that exact team in place. This can create concerns with the clinical trial team. I always like to ask: “Will the folks present actually work on this project?”
What is your number-one tip to align internal and external teams?
Really good communication pathways. Spell it out, write it out, have a communication plan. I discourage the team from having too much communication before the contract is complete as I don’t want them to give away our negotiation power. Good communication and a good specification are key.
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