Regulations Archives

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 Expediting Study Startup in Australia With Barrie Koh

Leave a Comment / Case Study, Video / By Paul Mirek

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.

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

Leave a Comment / Case Study, Video / By Paul Mirek

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.

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

News article / By Paul Mirek

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

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)
Harmonization
- Harmonize dossiers via SA application according to CTD
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.

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

Leave a Comment / White Paper / By Paul Mirek

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.

Click to read A Guide to the EU Clinical Trial Regulation