Brazil's bureaucracy a barrier to foreign CROs, says expanding Techtrials

09-Jun-2014 - Last updated on 10-Jun-2014 at 12:42 GMT

Bureaucracy is the biggest problem in accessing the Brazilian clinical research market, according to local CRO Techtrials, who says its expansion into the US was a far easier procedure.

Brazil is seeing an influx of foreigners landing on its shores as the football World Cup kicks off this week, but one company reversing the trend is Sao Paolo-headquartered contract research organisation (CRO) Techtrials who has expanded into the US with the opening of an office in New Jersey.

In the past few years, a number of US-headquartered CROs – including PPD, Covance, and inVentiv - have invested in operations in Brazil but according to Techtrials’ CEO Douglas Valverde, it is far easier the other way around.

“The company formation process is pretty straight forward in the US, with only minor adjustments [needed] to be in compliance with US laws,” he told Outsourcing-Pharma.

“The company processes are all basically the same since the clinical research international rules applies for both regions,” he continued, and though he said human resources are always challenging for CROs, Techtrials relies “on a very strong social media network.”

As for setting-up in Brazil, Valverde said the country’s bureaucracy was the biggest impediment across all industries, but added for the clinical trials sector there are a number of changes underway to increase market access.

“The Brazilian clinical research market is currently undergoing very important regulatory discussions within the Senate, ANVISA [Agência Nacional de Vigilância Sanitária], the Ministry of Health, the Medical Associations and Clinical Research Players.”

Competitiveness

Such collaboration will “increase the number of trials conducted in our country, especially the ones outsourced to big multinational CROs,” he said, though this will also benefit Techtrials whose “deep local knowledge” is amongst the factors that will keep it competitive locally.

Valverde told us Techtrials will also be competitive in the US, leveraging its “expertise as a Functional Service Provider (FSP) in Brazil to offer the same quality and dynamic services [it is] currently providing to top Pharma and Biotech companies.”

In the first four years of operations in Brazil, the CRO penned contracts with 16 of the top 20 pharma with servicesin oncology and hematology including FSP in Clinical Monitoring, project management, and pharmacovigilance, he said, and therefore the company hopes to bring “the same winning machinery” into the US market.