The clinical trial landscape is changing.
Historically, smaller pharmaceutical companies focused on preliminary research, which they sold to larger pharmaceutical companies that sponsored Phase 2 and Phase 3 trials.
That model has shifted as large pharma has become more focused on securing venture capital. In efforts to alleviate risk, today’s big pharmaceutical companies are less likely to sponsor trials themselves, and more intent on buying smaller pharma companies with existing data derived from successful clinical studies.
The burden of clinical trials, then, has shifted from large pharmaceutical companies to these smaller pharmaceutical companies, many of whom are sponsoring multi-continent trials for the first time. Larger trials are more complex than domestic trials in a number of ways.
- More regulation and moving parts
- QPs – Qualified Persons – are needed for EU releases
- In global trials, audits are required for facilities where drugs are manufactured and packaged
- QP releases are needed once a drug is ready and all certifications are complete
In light of these specifics, global trials require a Clinical Packaging Organization (CPO) with extensive experience in large, multi-continent studies. Small and medium sized pharmaceutical companies sponsoring today’s large trials turn to experienced Phase 2 and 3 CPO vendors but are learning the hard way that they’re not a priority to these businesses.
Large CPO vendors have a tendency to prioritize big pharma over smaller pharma, regardless of the size or scope of the trial. And it makes sense – the majority of their revenue comes from big pharma. But it makes for slower and more challenging trials for smaller pharma companies.
Big pharma ex-pats now working for small- and medium-sized pharmaceutical companies need to realize they’re not going to have the same relationship with larger packaging companies now that they’re with a smaller pharmaceutical company. If a large pharma trial needs extra rooms at the last minute, for example, small- and medium-sized clients’ trial needs get bumped. All in all, medium-sized pharma tends to get lost in the matrix of customer service, which can have critical consequences for trials.
Changes in the pharma industry have created a new reality: if you’re not large pharma, you don’t want to use a large CPO vendor.
At Xerimis, we’re dedicated to small and medium-sized pharmaceutical companies.
- We’ll never bump your trial in favor of a larger client. That’s not how we do business.
- We’ll help you navigate large, multi-continent studies even if you’ve never done a Phase 2 or 3 trial before.
- We’ll handle the complexities of global clinical supply so you can focus on the trial. You have enough on your plate as it is.
Xerimis is the only CPO in the industry who prioritizes smaller pharma AND has the experience to navigate large, multi-continent studies. This is our niche. We welcome smaller pharmaceutical companies because it’s the small and medium-sized companies that are doing trials rather than doing venture-backed acquisitions. You can rely on our experience and our guarantee that your trial will be treated as a top priority – no matter the size of the company behind it.