Deciding where to run your study can determine the success of a trial; from meeting patient enrollment and providing a positive patient journey to ensuring site expertise and a broad eligible patient population, choosing the right sites and countries to run clinical trials is crucial.
For Chinese biotech sponsors running global trials, the US is an obvious choice for running clinical trials due to the ability to collect vast amounts, and in some cases, the majority of study data, very quickly and in one place. In addition, the US is often a top choice for smaller biotechs seeking potential investors due to the visibility of trials.
However, sponsors should also consider the benefits of adding European countries to their geomix. Because many European countries have startup timelines similar to the US, adding these sites can further enhance overall timelines due to faster recruitment over a wider geographical area with additional patient populations.
PSI is a full-service CRO based in Switzerland that’s ready to support your global clinical trials with over 3,000 team members across 55 countries, spanning Asia, Europe, Africa, and the Americas. PSI has been continually recognized for excellence, including receiving CRO Leadership Awards in the categories of Expertise, Quality, and Reliability* for the past six years in a row.
Below are some additional ways PSI can provide support for Chinese sponsors as you plan your next trial:
- Minimizing your budget: Many countries in Europe may be less expensive to run trials, with timelines just as fast as US sites. PSI uses VISIONAL™, our advanced feasibility tool, to harness the power of machine learning to provide accurate enrollment forecasting, comparing hundreds of country and site combinations and their probability of success within just a few minutes.
- Overcoming regulatory hurdles: With our expansive European footprint and local teams, PSI can assist in navigating language and regulatory concerns such as data privacy (GDPR) from the European Union that may impact data robustness across international lines. Our regulatory experts in US and Europe have successfully supported more than 20 drug approvals in the last five years.
- Trial design and protocol review: Designing clinical trials with the patient journey in mind and providing a plan for globalizing a trial is crucial to mitigate slowdowns further in the process. PSI’s Scientific Advisory Board can help sponsors gather detailed feedback on the overall trial design and protocol to minimize protocol amendments down the line.
- Facilitating startup and recruitment: PSI’s Patient Recruitment and Site Support Specialists, along with our extensive vendor and site relationships, ensure tailored startup and enrollment plans at every site, especially when managing patient recruitment materials.
- Ensuring the quality of clinical data: PSI strictly follows Good Clinical Practice (GCP) principles to run clinical trials, ensuring high quality clinical data as well as the protection of subjects. We exhibit validated quality with more than 130 FDA and EMA inspections to PSI sites, with additional successful inspections this year.
* Overall (combined Big and Small Pharma) respondent group.
Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases, rely on PSI’s guidance and experience.
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