Taking new medicines to market is never cheap. But you don’t need us to tell you that. But escalating additional expenses, when the base cost is already high, along with increased regulation and scrutiny, is something that we all need to be concerned about.
Software validation is a necessary aspect of the process, but one that exacerbates the issue by further increasing costs and regulation. Because validation is a non-value adding activity in a non-core part of the business, this is a headache that small to medium-sized [CROs/Pharma companies] can do without.
IT and infrastructure costs for small to medium-sized for CROs/Pharma companies are particularly disproportionate, as they’re often unable to leverage the same economies of scale as larger organizations.
Investing and maintaining a validated statistical computing environment can be prohibitive, not least in terms of set up and recurring costs, but also in terms of time and personnel. Installing such an environment can take two to three full-time employees between six to nine months to complete. In-house expertise is also needed to ensure compliance.
Such an unnecessary use of resourcescan obviously have negative effects on both margins and overall competitiveness. What’s needed is an IT solution that solves these issues, effectively supports clinical trials, and frees you up to focus on bringing new drugs to market safely and effectively. And that solution is CAP.