CTA: What are the main outsourcing challenges you are currently facing?
EB: Initially the challenge is to select a vendor that has compatible capabilities for what you need on your project. Once a vendor is selected, the key is to ensure the vendor is engaged in your project. The level of engagement can definitely affect the quality of your project.
CTA: Could you give me an example?
EB: Well, on global studies, CROs in North America can tend to put the US sites ahead of Canadian sites, for various reasons and this can negatively impact the site start up times in Canada. Typically, for global studies it can take up to 6-8 months to get a site up and running in Canada (which is longer compared to the average in the US). It should not take this long.
CTA: How do you create a better relationship with your vendor?
EB: For globally driven studies, implementing a study advisor role within the affiliate is in my opinion a sound strategy that can be adopted to help improve relations with global vendors. For locally driven studies, the project manager can really work together with the CRO as though they were all part of the same team. This is particularly true when the CRO is contracted locally.
CTA : When partnerships don't work out, is there a correct time to part ways with vendor?
EB: It's really a question of what types of problem you are faced with, what budgets you have at your disposal and of evaluating the potential risk of keeping your current vendor, vs. the costs associated with having a new vendor rescue your project; the latter option often entails redoing some work that has already been done and requires time as well as dollars to do.
CTA: What kind of process do you have when it comes to the contract stage with vendors?
EB: Typically will have 2-3 vendors during the initial request for proposal but do not bring more than one full service CRO to the contract negotiations for local studies. It is normally a similar process for the global studies but could then have several vendors for various tasks depending on study needs and requirements.
My recommendation is to keep an eye out for accurate bidding and try to ensure that the project tasks are not underbid.
CTA: Some companies are considering the use of incentive clauses to help with accountability, what are your thoughts on doing this?
EB: I don't have any personal experience with incentive clauses implemented locally. They might work but would depend on the size of the vendor. I suspect this is more widely used with larger CROs. I cannot speak to what is done on our larger global studies for this.
CTA: What are your thoughts on the use of the multiple vendors?
EB: It depends on the size of your project and how you split up the work; for very large projects this might be beneficial even necessary. In the case of smaller projects, adding multiple vendors would only complicate matters and I recommend working with one full service vendor. If using multiple vendors, you would want to ensure a communication plan is in place to ensure everyone signs off on all required aspects, and follows the necessary deadlines. Your communication plan should have one central person coordinating the various vendor activities as well as an escalation plan.
We look forward to welcoming Elise as a guest speaker at the 2015 Outsourcing in Clinical trials Canada Conference which is taking place in Montreal this October.
Disclaimer: The views and opinions expressed above are those of the individual presenter and should not be attributed to Lundbeck.