Brazil is known as an attractive and important country for performing clinical trials due to its diverse ethnic population that is highly concentrated (more than 80%) in major metropolitan centers.
The ability to recruit large patient cohorts at fewer clinical sites offers an advantage to companies conducting pharmaceutical research in Brazil. In addition, the country has an extensive network of hospitals and clinical centers that provide high standards of care and therapeutic specialization.
While there are benefits to patient recruitment and clinical expertise, Brazil presents regulatory and logistical challenges. Companies seeking to begin clinical trials in the country face a complex path toward regulatory authorization as well as significant delays in import licensure and customs release.
Fisher Clinical Services Brazil is highly specialized in all aspects of the clinical trials supply chain and has helped many companies step through these obstacles. We invite you to learn more about our facility, services and solutions.
Daniel G. Fernandes, General Manager, Fisher Clinical Services, Brazil
Fast Facts on Brazil and Pharmaceutical Industry
Local and International Regulatory Support for clinical trials in this region
Sao Paulo Fast Facts:
Location: Southeast Brazil
Population: 11.9 million- city of Sao Paulo, 203 million- country of Brazil
Nearest Airport: Sao Paulo City/Guarulhos International (GRU) and Sao Paulo/Congonhas Domestic (CGH)
Distance from Airport(s) to Facility: 30 KM from Guarulhos International Airport
Fun Fact: Sao Paulo is one of the biggest cities in the world. It is the second city in consumption of pizzas and sushi due to the large Italian and Japanese colonies/influence. It has the biggest helicopter fleet due to the heavy traffic.
Key Benefits for Sponsors include:
A large pharmaceutical company was conducting multiple Phase II/ III trials in Brazil. Within the country, it was utilizing more than 40 investigational sites, handling primarily cold-chain shipments of biologics in insulated cold chain shippers designed to maintain 2-8°C for 48 hours.
The pharmaceutical companies had previously been managing multiple couriers within the country but was struggling with site complaints, temperature excursion issues and a burgeoning transportation budget. Specifically, the couriers utilized were:
As a result, the sponsor was facing costly IMP wastage and rush shipment charges, while sites were burdened with patient rescheduling. Concerned that these issues would continue to negatively impact trials in Brazil, Fisher Clinical Services Brazil was brought in to manage in-country drug delivery.
Immediately, the Fisher Clinical Services Brazil team compiled a list of all sites and reached out to each one via phone in order to compile a list of critical site information, including authorized personnel names, working hours, and days/times available for shipment receipt.
With oversight of all Brazilian shipments, the Fisher Clinical Services Brazil Logistics Coordinators pre- scheduled 100% of site shipments by phoning each site in advance of every shipment. The project management team confirmed the sites’ availability to receive material on a specific date. While on the phone, they were able to review storage and delivery conditions as well as discuss any issues that the site may be experiencing. Sites were provided a contact name, phone number and email address in the event they experienced any issue. Since the Fisher Clinical Services team was in direct contact with the courier company, any site issue that arose was quickly resolved.
The local availability of Fisher Clinical Services staff, the proactive oversight of shipments and the active communication with in-country sites in their local language, eliminated the following courier issues and improved overall trial performance:
Pre-alert notifications to investigational sites in local languages, with track and trace capabilities and proactive management of couriers are available in countries across the globe through Fisher Clinical Services. Ask your account executive for more information.
Dedicated logistics team speeds up importation process
Despite the substantial progress being made toward global regulatory alignment in Latin America, customs requirements continue to evolve and often differ significantly amongst even neighboring countries. Early planning is essential when importing supplies into Latin America.
Our client, one of the top 10 leading multinational pharmaceutical companies, was conducting multiple Phase II/ III trials in Latin America with particular emphasis on Brazil. Whilst the Sponsor had partnered with Fisher Clinical Services to fully manage its transportation strategy, there was one element of the overall supply chain strategy that had been kept in-house. For historical reasons, the Sponsor continued to use its local office in Brazil to act as Importer Of Record (IOR).
The role of Importer Of Record
The Importer Of Record is a legal entity responsible for:
The Sponsor was experiencing continued delays to the importation of supplies which was impacting on deliveries to patients at investigator sites. Factors contributing to these delays included:
Fisher Clinical Services to handle importation
With a track record of excellence in importing clinical supplies into Brazil since establishing a dedicated import/export team in 2012, the Sponsor made the decision to appoint Fisher Clinical Services to handle the importation processes into Brazil.
The client recognized that Fisher Clinical Services Brazil successfully facilitated the importation process for investigational drugs, placebos, biological drugs, controlled drugs, comparator drugs and ancillaries.
Regulations RDC 39/2008 & 09/2015
Today clinical trials can be submitted to the Brazilian MOH ANVISA through different regulations:
With oversight of all Brazilian shipments from end-to-end, the Fisher Clinical Services Logistics Team was able to manage the customs process as well as preparing the ‘Nota Fiscal’ to release all shipments faster than the Sponsor’s local office. Significant time savings were achieved due to proficient documentation review and faster payment of taxes & duties. Customs clearance was streamlined via an established network of broker contacts fully versed on the importance of maintaining integrity of supplies for Fisher Clinical Services’ shipments.
Benefits to the Sponsor
Global Reach & Compliance
Leveraging its global network of strategically located cGMP facilities, logistics expertise and in-country experts, Fisher Clinical Services is in the unique position to handle the entire supply chain from start-to-finish, including the provision of Importer Of Record services in 24+ countries. Sponsors are assured that Fisher Clinical Services is fully vetted and compliant with regional and country-specific laws related to the provision of Importer Of Record services.