Global Reach

Benefits of PSI Global Support for Chinese Biotech Sponsors  

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.

Learn more about how working with trial sites in China can help support your upcoming global study or contact us today to learn how PSI helps support sponsors around the globe.

* Overall (combined Big and Small Pharma) respondent group.

About Us

For 25 years, we have built trusted relationships with biotech sponsors, with 90% of our customers being repeat and referral. 

Therapeutic Areas

Clinical trial sponsors working in oncology, hematology, IBD, infectious diseases, multiple sclerosis, and many rare diseases, rely on PSI’s guidance and experience.

Applying for Multiple Phase Studies in China With Lisa Lu

Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?

Benefits of PSI Global Support for Chinese Biotech Sponsors   Read More »

Strategies for Working with NGS Testing on Site in China

Did you know that NGS testing in China can be expedited with the right site relationships? 

As treatment options move towards enhanced personalization, NGS testing, or specific gene mutation testing, has become increasingly common as part of modern oncology and hematology clinical trials. When PSI Shanghai was contacted about a specific oncology trial requiring NGS testing, the team was able to contact 24 sites with relevant indication experience, and within 3 days, received interest from 15 of those sites to participate. 

In order to accelerate patient enrollment, PSI engages a trusted network of highly qualified sites to ensure that each trial’s needs are met with specific experience. Learn more about NGS testing in China with Lisa Lu, Country Manager.

If you have a phase 2/3 clinical trial requiring NGS testing, consider clinical trial sites in China. Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Discover more about our oncology and hematology experience here or contact us to speak with an expert today.

Transcript:

Did you know the NGS testing status in China?
Modern Oncology and hematology trials often require specific mutation testing, as we all move to a more personalized
medicine in time.
While this NGS technology is well established in China, it is not used in every study yet.
We still have capacity here. Let me share with you some recent cases.
We recently had a request for a specific oncology trial to be run in China. The protocol required sites being able to run the
NGS testing in screening phase. PSI’s Shanghai team contacted 24 sites with study experience in this indication.
Overall, the sites’ attitude was positive.We only had 3 days to check our sites. Among all of them, 15 sites expressed immediate interest and had the relevant
NGS experience and equipment.
The results show that NGS testing is not a show stopper for any modern trials which need this measured in China.
Looking forward to seeing you in Shanghai.

Strategies for Working with NGS Testing on Site in China Read More »

Strategies for Expediting Study Startup in Australia With Barrie Koh

Did you know that Phase 2 and 3 study startup times in Australia can be expedited with the right site relationships? In order to accelerate the first patient in, PSI engages private sites and medical centers to ensure an average startup timeline of only five months. Learn more about study startup in Australia with Barrie Koh, Country Manager.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, I’m Barrie. Did you know that Australia is quick to start up?

Everyone in the industry knows that it is easy to get an approval for an early-phase study in Australia. It is supported by streamlined regulatory processes, and you just need fewer documents for submissions. What most don’t realize is that startup in Phase 2 and Phase 3 isn’t that different.

The challenge is that most clients have a habit of going back to the same key opinion leaders or the huge institutions. they have lots of studies and they are heavily bureaucratic. To get to the first patient in quickly, PSI has been engaging the private sites, which are much more agile, only working with four to five huge private medical centers and a dozen more smaller sites.

With this particular approach, five months is feasible and it is consistent across all phases, all therapeutic areas and drugs classes. To cite you an example, in a recent microbiome study, we actually managed to achieve the first patient in in five and a half months at a private site down in Sunshine Coast. And this came in two weeks ahead of our planned first patient in.

Another example is a gene therapy study that we’re currently running. We were the first CRO to apply for a gene therapy license (in Australia). So we actually worked with each other to try to move this forward and this was done under four months itself and ever since then, we’ve completed four more gene therapy studies.

Strategies for Expediting Study Startup in Australia With Barrie Koh Read More »

How to Apply for Phase 1 and Phase 3 Studies in China at the Same Time With Lisa Lu

Did you know you may be able to run Phase 1 and Phase 3 studies in China in parallel, particularly for urgent medical needs?

Hear Lisa Lu, PSI CRO’s Country Manager in China, discuss how to determine if your study may qualify and how PSI’s local experts can help.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hello, my name is Lisa Lu. I’m the country manager for PSI in China and I’m located in Shanghai. Let me share with you some relevant aspects for running clinical trials in China.

Did you know that for new drugs coming to China, it is needed to conduct a PK study in a Chinese population locally? One can apply for an IND for Phase 1 and Phase 3 studies at the same time.

Based on NMPA’s feedback, you can potentially run Phase 1 and Phase 3 studies in parallel. Urgent medical needs like hematology studies, and lethal diseases without any drugs available at the moment, have a higher chance in running Phase 1 and 3 studies at the same time.

Usually, a PK study needs 20 to 30 healthy volunteer subjects or patients, depending on the different indication and medicine.

How to Apply for Phase 1 and Phase 3 Studies in China at the Same Time With Lisa Lu Read More »

How Do India Study Startup Timelines Compare? With Radhika Bobba

How did we achieve site activation for a radiopharmaceutical study in India in less than 5 months? It turns out India study startup timelines are faster than many European countries.

Learn more in this video with Radhika Bobba, PSI CRO’s Regional Director, India and Far East Country Management.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

India startup timelines are always discussed. “India is so slow, it’s so difficult to set up a study, it’s so difficult to start a study.” Let me give you a recent example.

We submitted a dossier for a radiopharmaceutical molecule in oncology on the 3rd of August, 2021. We received approval for this particular dossier on the 2nd of December, 2021 from a regulatory authority, the DCGI. It took us five months. The first site was initiated on the 14th of December, 2021, and the same site was activated on the 28th of December, 2021.

5 months, is it so long?

Yes, we are definitely not the fastest. We are definitely not the slowest. We can be compared to other countries in Europe. We can be compared to France, Italy, Germany, Switzerland. We are faster than Romania.

How Do India Study Startup Timelines Compare? With Radhika Bobba Read More »

Debunking Latin American Study Startup Myths With Oscar Podesta

Did you know that startup timelines for some countries in Latin America are comparable to those of many in Europe?

Hear from Oscar Podesta, PSI’s Head of Latin America, as he shares insights debunking some of the common myths about startup duration in the region.

Around the world, PSI CRO is working to ensure studies deliver on time and on budget. Find the nearest office to you and start a conversation.

Transcript:

Hi, my name is Oscar Podesta. I’ve been responsible for the Latin American region at PSI for almost 10 years now, and I wanted to briefly address one of the most frequent comments I receive about my countries here that is related to the startup timelines.

I think that these days we can call it a myth around Latin American countries being too slow to get started in clinical research trials, but I do remember those years where this was true—I mean when Latin American countries used to take just too long to get activated, but that’s not the case anymore, and it has not been the case for quite some time already.

These days, if you look only at statutory timelines, we can say that countries like Panama or Chile can be activated in less than six months, which is comparable in line with many countries in Europe. And even looking at bigger countries, like Argentina, for instance, our statutory timelines there are comparable with Germany, actually could be even shorter than the UK.

So, looking at overall just First Site Activated in countries in the region, our timelines are not longer than the rest of the world in general. But I think we have to look at that in more detail. And if we look at the data we have at PSI, our track record and metrics, and we actually look at the average time to activate all sites in a country—not just the first site activated, but all sites—that provides even more interesting information.

At the end of the day, we need all sites activated to make the enrollment for the study, so it is important to have the whole country active. And looking at those data at PSI, we find out that countries like Argentina, Chile, Panama, and Peru are actually shorter than several western European countries.

And let’s take another step into that and look at the bigger countries in the region, like Brazil or Mexico. Brazil right now is hitting more than 200 million people living there. So it’s huge, as everybody knows. And historically, everybody would say, “No, I wouldn’t go with the study to Brazil because it takes too long”—and it’s not the case. It’s not the case.

Right now there are a lot of indications, especially rare diseases, that are branded fast-track review by the authorities in Brazil, and a rare disease study can easily be activated in Brazil, maybe in six months, which puts the country in direct competition to pretty much any country in the world. So, the myth or the statement about Latin American countries being too slow, I don’t think it’s anymore not even fair to say.

Debunking Latin American Study Startup Myths With Oscar Podesta Read More »

Transition Your Ongoing Study to EU Clinical Trial Regulation in 3 Steps

After being adopted by the European Parliament in April 2014, the European Union’s Clinical Trials Regulation (Regulation (EU) No 536/2014) officially took effect on January 31, 2022. The regulation aims to improve the harmonization of the approval process for clinical trials and make the region more attractive as a destination for clinical research.

If you are a sponsor of active clinical trials in the European Union, you may have additional responsibilities under the new Clinical Trials Regulation. But don’t worry. Here are the steps for transitioning an active clinical study in the European Union to the new requirements under the EU Clinical Trial Regulation. For a more in-depth look at the changes, you can read our new white paper A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies.

Steps for Transitioning Ongoing Studies

  1. Sponsor Evaluation
    • Evaluate your clinical trial’s current compliance with the Clinical Trial Regulation and identify the need for transition
    • Determine whether the dossier needs to be harmonized between Member State Committees
    • Confirm if the clinical trial is eligible for transition (no pending/ongoing assessment in any EU or EEA countries)
  2. Harmonization
    • Harmonize dossiers via SA application according to CTD
  3. Transition
    • Make formal application for transition (simplified dossier, no re-assessment!) in the new Clinical Trial Information System
    • A new cover letter and new application form module are required to be completed in CTIS (see Figure 1)
    • For multinational clinical trials: Sponsor’s declaration that part I/part II documents do not contain significant differences/are identical to the versions approved by each Member State (as applicable)

Figure 1. Documents required to be uploaded in the CTIS for transition

The standard timeline for the review of the transition application is 60 days. During this period, the trial cannot be amended. If and when the trial undergoes the next substantial modification following the date of applicability, the full requirements of the new CTR will apply.

As a privately owned and operated contract research organization headquartered in Switzerland, PSI CRO has continuously monitored and adapted to the changing European regulatory landscape over the last 25 years. Drawing on this experience, we can offer a unique perspective on preparing for this shift in how clinical trials are conducted in the EU. Click here to read our new white paper or get in touch with one of our regulatory affairs experts.

Transition Your Ongoing Study to EU Clinical Trial Regulation in 3 Steps Read More »

A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies

With the European Union’s Clinical Trial Regulation coming into effect on January 31, 2022, we know there are many questions when it comes to what’s changing and what you need to do to comply. That’s why PSI CRO, drawing on our 25 years of experience managing studies across the globe, is sharing our insights in a new white paper.

In A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies, you’ll learn:

  • The new elements introduced by the EU CTR
  • The applicability for current studies
  • How to transition your study to the new requirements

Click the image below to start reading or download a copy.

A Guide to the EU Clinical Trial Regulation: How to Ensure Timely Transition for Current Studies Read More »