Video

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.

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.