It's no secret that carrying out a clinical trial is a complicated process. The complexity of a trial means sponsors must rely on outside help in order to meet deadlines and ensure their product gets into the market as quickly and safely as possible. But for the sponsors who take on multiple vendors at the same time, how do you manage them effectively? Here are some tips and strategies to consider when carrying out a trial.
Facilitate continuity throughout your supply chain when multiple vendors are onboard
Sponsors must do their homework and due diligence when sourcing vendors. Communication is key, set clear standards and make sure vendors are involved in the contractual process. Sponsors, large and small, must set firm timelines and tell vendors what they need upfront. Sponsors also need to be flexible to meet the demands that come with handling multiple vendors.
Even though you may be placing a lot of responsibility on the CRO's shoulders, it can still be challenging because you need that product delivered in a way that you need to be.
Early engagement among all parties (from sponsors to packaging vendors or distribution vendors) is essential. Depending on the vendor, you may want to meet frequently, especially if you haven't dealt with the company before. On the flipside, if you have a good working relationship with a vendor and a degree of trust has been developed, then you may not have to meet so often. What's crucial, however, is that everyone needs to be on message.
How do you manage an underperforming vendor?
Sponsors must have a review process to assess what's gone right and what's gone wrong (KPIs) to ensure vendors are meeting their targets. Always liaise with your partner, keep in close contact, but importantly, have a back-up plan in the event you fire a vendor.
When things aren't going according to plan, sponsors may have to intervene and assume more leadership. Ensure you visit the sites to make sure they understand what they're doing, what the issues are, so they can correct anything that might be wrong. Also, audit and review the systems and processes your vendor is using.
Before you get to the point where you have a problem with your vendor, go back and see what the communication looks like, be introspective and ask yourself whether there were enough meetings, and so forth. You may want success but what does success look like? You need to be very clear with your vendor and you need to be firm. While you may be flexible, there needs to be no wriggle room on what success for you looks like.
However, it's important to remember vendors want to do well; they aren't trying to do badly. Clinical trials are their livelihood as much as it is yours.
Weighing up the additional time and resources used when managing multiple vendors compared with full outsourcing
For every sponsor who has had to juggle a multitude of projects at the same time, there comes a time where you realise you can no longer handle the workload. At that point, you may decide it's best to add more time to finish your trials, or to outsource certain aspects. While it's good to look at and compare various models, it really comes down to the level of control you have. If you're going to fully outsource a trial, examine how much control you have over the process and how much control you need. It is vital that you as the sponsor have control, even when outsourcing parts of your trial. It will prove very helpful with your timelines as well as your resources.