Optimizing Clinical Trial Operations

"Having a one-stop-shop vendor that is able to cover all the aspects of any project, at any phase and in any indication, is very beneficial for the sponsors, as there are multiple savings from a financial as well as timeline perspective," says Alexander Fetkovsky, CEO, SanaClis.

SanaClis is a solution provider at the marcus evans Evolution Summit 2023 and the Evolution Europe Summit 2023.

How has the clinical supply chain landscape changed? 

The landscape has changed globally, due to the pandemic and more recently with the war in Ukraine. On the other hand, new molecules being developed in clinical trials today are increasingly more complex, requiring a more advanced supply chain, shorter timelines for moving products from one place to another, and special storage conditions. This is not just more expensive. It also requires more experienced professionals to manage the supply chain properly.

Why did you decide to open a new depot in California? What gaps will it address?

Being closer to our clients will be beneficial not only for us but also for our clients, and lead to financial efficiencies. Around 40 percent of the biopharma industry in the US is located in California, and yet California is not so crowded with vendors like New Jersey or Pennsylvania. California is also the biggest contributor from a recruitment perspective in the US. The weather conditions are more stable and it is one of the main transportation hubs in the country, as well as globally, with easy access to international and local routes. Given the time difference with the East coast, it gives us added time to run operations even once our competitors are done for the day. Our portfolio and coverage bring significant benefits for a sponsor. Our new depot will allow us to fill a big gap in the market.

What are the benefits of having a CRO with a supply chain wing? 

Having a one-stop-shop vendor that is able to cover all the aspects of any project, at any phase and in any indication, is very beneficial for the sponsors, as there are multiple savings from a financial as well as timeline perspective. Achieving the result on time or ahead of time is critical. If sponsors have multiple vendors, they need to bring three or four vendors on the phone to solve an issue. That can take weeks and potentially lead to significant delays.

Every day of delays in a clinical trial results in a financial loss. There are also indirect loses, because the later you potentially come to market, the later you start selling your product. Your competitors may even reach the market before you do. It is very important for every single sponsor to be as efficient as possible.

What advice can you offer on vendor selection? What mistakes do some sponsors make?

Sponsors expect that the largest CRO will deliver the best service, but they often overestimate the actual capacities of the vendors. The whole industry is understaffed, as companies are constantly looking for candidates. Our approach is slightly different as we continuously invest in young talent. We target promising graduates who have just finished university, and we invest in their education and development within the clinical trials industry. We then provide them with hands-on experience, by appointing them as supporting staff on projects, without an extra charge to the client. Often times when our clients begin another study with us, they request those same trainees they worked with in the past, to this time around be their CRAs because of the trust and great relationship built. This is a great example of how we grow organically. I would strongly recommend sponsors make sure their vendors are not understaffed and check how many projects the CRA is managing. If he or she is managing multiple projects within different therapeutic indications, it is very likely that there will issues during the project. At SanaClis, our teams are allocated between a maximum of one or two studies in parallel, as we focus on quality and we put talent at the forefront of our company ethos.