When you're on the verge of initiating a trial, identifying a vendor can present a wealth of challenges. Numerous talks and presentations have discussed at length what key aspects sponsors should look out for when selecting their preferred partner. So what should sponsors look for in the perfect vendor? And once a partner has been chosen, what governance and oversight strategies should the sponsor implement to ensure their trial is conducted without hitch? CTA spoke to Marie Anne Stager from Seattle Genetics to discuss some of the ways to enhance the sponsor-CRO dynamic.
Clinical Trials Arena: How do you optimize strategic partnerships between sponsors and CROs?
Marie Anne Stager: I would say it depends on how you position it from the beginning. That to me is a key factor. Making decisions internally first on why you are looking at a preferred model, being transparent with all if that's the direction in which you're going, is critical while paying a lot of attention to the change management piece. When it comes to choosing a partner, choosing well is key to start with.. It's important to know what's important to your company; it's not about who other people think is a good partner, it's who you think is a good partner, who's the right fit for you. It's not a one size fits all. Developing and maintaining a good relationship is critical.
CTA: In your experience, what have you found to be the key things you look for in a vendor?And once you've found one, how do you go about developing a relationship with a vendor to ensure everyone's on the right page and everyone gets off on the right foot?
MS: For us (Seattle Genetics), a lot is about flexibility and being able to be practical with the vendor. But most of all, it's really about the relationship building. When you've found a vendor that you're happy with, I think it's about being willing to have the honest, direct conversations early; that can be for talking about vision, for challenges (both sides of the fence - the positive and the negative if you will). Honestly, it's all about not letting things fester, it's having everyone be comfortable and knowing that they're going to be backed if they're going to have a difficult conversation. Sometimes the difficult conversations are within your own company, so it's within your own company as well as externally with your vendor that you need to be prepared to have them to set up a successful relationship. I find these conversations need to happen in order for things to move forward. To me, over my many years of managing projects and teams, I think that's the one thing that cripples teams the most; they're too afraid to say what they need to say, and they just need to know you can find a respectful way to talk about the important things.
CTA: Once a trial is underway, how do you engage with vendors to ensure they meet your needs?
MS: It's important to build in a number of periodic meetings, you build in the type of status reports you want to see, you decide what are the things you want to look at on a periodic basis and how frequently. From there, you really need to pay attention to what those key indicators are and that's what I mean by having conversations early. Sometimes you don't have to wait for data; if your gut tells you that you sense there might be an issue with something don't wait for the data, start talking about it before you even see the data. It's not too early. It's never too early.
CTA: In the event when a vendor is perhaps not meeting your expectations, how do you deal with those setbacks?
MS: I don't deal with it any differently than when I have someone reporting to me. You have to ask questions, you want to get their perspective, you see things a certain way - the way they see things, you have some good, honest dialogue about it and decide what the next steps are. Something has to change because you've seen something that's not acceptable.
CTA: Do you think there's a negative perception of vendors?
MS: Yes, I do. I don't think the industry does enough to pay attention to the good things that are happening. There are plenty of good things that vendors do for sponsors, and somehow sponsors get into a cycle where they only focus on what's not working, they don't focus on what's working. I feel that sends people off down the wrong path.
*Marie Anne Stager is the Executive Director of Clinical Development Operations at Seattle Genetics