For small companies conducting their own trials, managing data can be burdensome task. As technologies advance, companies can accrue more and more data at the drop of a hat. So how do you manage big data?
Christoffer von Sehested is the director of Clinical Operations at Veloxis Pharmaceuticals. Veloxis is a small company with a team of three people involved in the heart of clinical operations. They oversee everything from trial design and writing up study reports to managing data.
CTA sat down with Christoffer to gain insight into life at Veloxis and to learn more about the issues he encounters on a daily basis.
Clinical Trials Arena: What are some of the biggest challenges you face?
Christoffer von Sehested: The greatest challenge is to manage your vendors and have the right systems in place. We do not have a setup where we always use this vendor for this or that and have a full blown CTMS (clinical trial management system). The only things we have are some preferred providers that we change from trial to trial. It’s a test of endurance to keep ahead of things and make sure we receive all the data. When they come from different vendors the data we receive tends to be in different formats. Therefore, we need to ensure we can find them again internally. You need to be aware of aligning between studies so you can use it moving forward.
CTA: As you’re a small biotech company, do you depend a lot on vendor services to conduct your trials?
CvS: For our recent global phase III program we relied heavily on vendors. As we will soon launch our product in the US, we’re adopting a new approach where, as we grow into Phase IV, the idea is to conduct more and more trials in-house. The problem here now becomes more about data storage and managing data because we don’t have the systems to do this. Ordinarily we relied on aCRO to do this, and now we have to look through what we have earlier and how we would like to get something set up to get similar information from the studies we manage.
CTA: Since taking on more trials in-house, how have you found managing all of the data on your end?
CvS: We’ve started to develop a process that I think we’ll be fine tuning over the next 20 years, maybe! I find initiating projects very challenging, but enjoyable. I like the idea of figuring out how to make processes better and more efficient. In the long run when we conduct more studies and we find a system that works, I think managing the data will become even more difficult. We are looking for possible solutions, for instance, using a CTMS that will enable us to manage both our own study data and our vendor’s because there is a lot of data to collate in excel sheets.
CTA: From your perspective, what advice would you give to similar companies (in terms or managing trials and collecting data)?
CvS: I would reach out to vendors and colleagues in other companies and ask what they did. I have started to build a network where I exchange ideas either to start new processes or to work smarter. For instance, we work closely with an EDC (electronic data capture) provider. I asked that vendor whether they had other users in a similar situation and they directed me to a few people I could call. That, to me, has been hugely beneficial. Creating a network allows you to meet people who face the same challenges and have many good ideas on how to go about it.