SaoPaulo1

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

  • 5th largest population in the world.
  • More than 80% concentrated in urban areas.
  • 7th largest economy in the world.
  • 6th largest pharmaceutical market.
  • Emerging large biosimilar industry.
  • Diverse ethnic population.
  • Fast enrollment of large patient groups in oncology, cardiovascular, diabetes, CNS and rheumatoid illness.
  • The regulatory agency responsible for the clinical trials approval, pharmaceutical products registration and specific importation licenses is ANVISA.
  • Majority of pharmaceutical clinical studies are submitted for approval by pharmaceutical industry, CROs and university hospitals.

SaoPaulo-About

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.

City:
Sao Paulo – SP
Country:
Brazil
Opened:
2008
Total Capacity:
1,200 m2
Secondary Rooms:
2
Cold Production Rooms:
1
Warehouse Capacity:
7,700 m3
Ambient Storage Capacity:
3,000 m3
Refrigerated Storage Capacity (2-8):
1,500 m3
Frozen Storage Capacity (-20):
100 m3
Controlled Drug Storage Capacity:
70 m3
Controlled Drug Refrigerated Storage Capacity:
30 m3
Environmental Technologies:
Yes
Audited:
ANVISA
Comparator Sourcing:
Yes
Returns & Destruction:
Yes
Labeling:
Yes

SaoPaulo-benefits

Key Benefits for Sponsors include: 

  • Strategically located in the city of Sao Paulo (main and largest metropolitan area in South America), about 30km from the largest international airport and a few minutes from the main domestic airport with connections to all regions of Brazil.
  • A high standard cGMP facility audit by ANVISA.
  • High level of security (24 hours / 7 days a week) and biometric access control.
  • Import of Records and customs broker services.
  • Cold chain capabilities and expertise in storage, handling and distribution of temperature sensitive products.
  • Labeling services capabilities.
  • Licensed and certified returns and destruction services.
  • Highly experienced team can support you from logistic Project Management through destruction.

Case Study: Improved Site Delivery

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:

  • Failing to deliver the shipment to the authorized person at the site. As a result, shipments were either not delivered or the shipment was delivered to an unauthorized person and misplaced or mishandled.
  • Delivering shipments outside of the investigational sites’ working hours, without notifying the site in advance or arranging for personnel to be available after hours.  For investigational sites in cities at a significant distance from the depot, extensive temperature excursions were being documented when shipments were left at the facility outside of working hours, improperly stored or returned to the depot outside of the 48-hour window.

 

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:

  • Shipments arriving after a site closed or when no authorized personnel were available.
  • Shipments delivered to unauthorized personnel
  • Temperature Excursions as a result of improper storage or lack of timely receipt of material.

 

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.

Case Study: Importation Process Leadtimes

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:

  • Ensuring the imported goods comply with local laws
  • Filing a completed duty entry & associated documents
  • Paying the assessed import duties & other taxes on those goods

Challenges
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:

  • Many hand-offs across the supply chain between different entities
  • Uncertainty of roles & responsibilities of all parties to the supply chain
  • Lack of visibility of supplies
  • Slow processing of supplies through customs

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:

  • RDC 39/2008 – import license needs to be authorized PRIOR to shipping supplies to Brazil
  • RDC 09/2015 – import license is required AFTER approval at the Brazilian airport

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

  • Improved process efficiency
  • Reduced number of handoffs giving lower risk of miscommunication or document handover
  • End-to-end visibility of supplies allowing intervention where necessary
  • Secure chain of custody, control & compliance
  • Continued reduction in lead-time by a total of 11 days
  • Improved investigator site satisfaction because of fewer delays
  • Faster delivery of clinical supplies to patients

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.