loc-buenosaires

Thank you for visiting Fisher Clinical Services, Argentina

Over the past decade there has been a notable shift in target locations for clinical research – away from the more traditional locations of the USA and Western Europe, across to the Asia Pacific region and Latin America. Argentina, the eighth largest country in the world, the second largest in Latin America, is an attractive location for clinical research for many reasons – access to large pools of treatment naïve patients eager to make a contribution to science and to participate in clinical trials; an established infrastructure with a high concentration of the population in urban areas; easy recruitment, fast enrollment and high retention rates; well trained healthcare professionals; and a well established regulatory body ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica).

“Fisher Clinical Services Argentina was established in 2004 to provide a breadth of services to support global pharmaceutical and biotech companies wishing to conduct clinical research in Argentina. With Subject Matter Experts primed to overcome regulatory and logistical challenges, the ultimate key to success in this culturally diverse region is a team of local people with a true appreciation of how to conduct business in a way that accommodates cultural nuances. We invite you to find out more about our facility.”

Jonathan Klawir, General Manager, Fisher Clinical Services, Argentina

cGMP facility and home to our dedicated Latin American Clinical Logistics Team

Buenos Aires Fast Facts:

Location: East Argentina
Population: 40 million
Nearest Airport: Ministro Pistarini International (EZE) and Jorge Newbery (AEP) Domestic Flights
Distance from Airport(s) to Facility: EZE 35 and AEP 10 km (21,7 and 6,2 miles)
Fun Fact: Tango originated on the streets of Buenos Aires and this passionate dance can still be seen performed daily on the streets of San Telmo.

City:
Buenos Aires
Country:
Argentina
Opened:
2004
Total Capacity:
1,655 m3
Secondary Rooms:
1
Warehouse Capacity:
670 m3
Refrigerated Storage Capacity (2-8):
130 m3
Frozen Storage Capacity (-20):
9 m3
Controlled Drug Ambient Storage Capacity:
35 m3
Environmental Technologies:
Yes
Audited:
Local MoH and Government of the City of Aires
Returns & Destruction:
Yes
Labelling:
Yes


Key Benefits for Sponsors

Home to our dedicated Latin American Clinical Logistics Team:

  • A pioneer in the region, offering specialized services in clinical supply chain management
  • Wholly-owned facility designed in compliance with cGMP/cGDP/cGCP guidelines
    –  10+ years of experience in the region
    –  Proficient management of 300+ clinical supply chain projects
    –  Handling 20,000+ shipments to investigator sites per year in the region & 7,500+ shipments to Argentina
    –  Subject Matter Experts in all aspects of the clinical supply chain
    –  Close working relationships with investigator sites, Contract Research Organizations and local Sponsor affiliates
  • Highly experienced and well trained Project Management team
  • Excellent communication skills with multi-lingual points of contact
  • Established relationships with regulatory bodies in-country
  • Technical and regulatory advice for clinical supplies distribution management
  • Import process support- process set-up; commercial invoice; broker engagement
  • Offering insight into regionally appropriate packing/shipper configurations particularly for cold chain supplies
  • High local QA standards harmonized with company global QA policies
  • Expert logistics support for IMP and non-IMP materials
  • Global information technology systems with complete tracking and traceability of inventory
  • Diverse storage capacity for ambient, cold chain and frozen materials
  • Secure storage capacity for controlled drugs
  • Returns & destruction capability in line with local regulations

Ensuring Cold Chain Supplies Maintain Temperature Specifications Until Delivery to Site

The follow-the-patient trend to placing clinical trials in regions with large pools of treatment naïve patients has driven trial locations to an increasing number of countries where the climate is hot, including Latin America. To distribute cold chain IMP to multiple countries within Latin America means juggling a variety of requirements such as import and export rules, local regulatory requirements, varying courier and carrier performance, knowledge of local temperature and transportation variations. This places additional pressure on all parties to the supply chain who must be able to maintain the integrity of supplies within specified strict temperature controls.

Complex cold chain specifications
A leading global pharmaceutical company contacted Fisher Clinical Services with a view to running a multinational clinical trial across many continents including Latin America. The perceived complexity of this multinational clinical trial, with significant volumes of cold chain products being distributed across many continents with different climate zones, prompted Fisher Clinical Services to establish a “review committee” to discuss the proposed study set-up including many aspects of this complex trial – packaging, labeling and distribution.

In this instance the project managers based in Fisher Clinical Services Argentina quickly highlighted the fact that the proposed packaging configuration for the cold chain clinical supplies was not appropriate for the Latin America region. The Sponsor’s packaging vendor had based configurations on Northern Hemisphere climates and temperatures. Immediate action was taken to modify the packaging configurations to include additional gel packs. This new measure would ensure that clinical supplies would maintain specified temperature levels from point of dispatch to delivery to investigator sites.

This rapid intervention by Fisher Clinical Services Argentina delivered significant savings to the Sponsor through excursion avoidance and management of the original drug supply. No replacement IMP was needed for the duration of the trial.

Remote site locations
An additional complication was the remote location of some of the investigator sites in Argentina. Fisher Clinical Services worked closely with the Sponsor to define the best distribution model for the clinical trial supplies, realizing cost and performance efficiencies across the supply chain. Fisher Clinical Services Argentina in partnership with leading freight companies in the region and with local freight companies in more remote locations, ensured the seamless replenishment of clinical supplies to investigator sites. Proactive communication by Fisher Clinical Services to the investigator site staff helped smooth the delivery of cold chain supplies to the sites also accommodating patient appointment schedules. The clinical trial study and the patients were not compromised in any way.

Fisher Clinical Services Argentina continues to support leading global pharmaceutical and biotech companies with the smooth distribution of cold chain clinical supplies across the region.

Ensuring Distribution Through the Vicissitudes and Against All Odds

On April 22, 2015, the Calbuco volcano in Chile erupted and expelled a huge column of smoke and ash that reached four kilometers high. In addition, the Andean wind shifted to the north of the Patagonia in Argentina affecting Rio Negro and Neuquén provinces.

This natural disaster was a major concern for the Fisher Clinical Services Logistics Team. For clinical research centers located in these provinces, it was business as usual, but shipments of medication to these destinations presented challenges on the days following the volcanic phenomenon.

A warning was issued by the Courier Company “Flights to Neuquén, Bariloche and San Martin de los Andes are canceled”. This warning would lead to further complications and challenges for the Fisher Clinical Services Logistics Team as a very high percentage of shipments were ‘cold chain’ clinical supplies. It was imperative that these clinical supplies were kept in defined temperature specifications. Temperature excursions would jeopardize the stability of these clinical supplies, in turn jeopardizing the Sponsors’ clinical trials.

Working together
Working together, the Fisher Clinical Services coordination team and the logistics team, joined efforts in order to agree on the best way forward to enable the delivery of clinical shipments to patients over the coming days. Both teams worked together to define a new strategy. Firstly, they reviewed the shipment plans for the forthcoming days and prioritized shipments according to patients’ schedules. They set up an internal schedule and made a decision to constantly monitor all shipments in real time. The instructions were clear and they knew that accomplishing this, would mean a great benefit to the Sponsor and more importantly, to the patients.

Then the Logistics Team worked with the authorities of the National Airport to get an appreciation of flight schedules. Further communication revealed that, in fact, only 1 of 3 flights had been cancelled over the next few days. A complicated situation was turning into a more hopeful scenario.

Communication – 3 way
The last point of contact on the clinical supply chain was the investigator site. Close follow-up and a constant flow of communication between the three teams (Fisher Clinical Services Logistics Coordinators, the Courier team and the investigator site personnel) was essential. The investigator site staff were pre-notified about proposed shipment delivery dates to the investigator site, alerting them to be ready to receive their shipments. It was a race against the clock in addition to a race against the weather.

Outcome
The scenario was prepared to accomplish an effective delivery: the flight of that day was delayed, but no other adversities were identified. All parties to the supply chain were primed to expect the delayed delivery. Fortunately, and as expected, 1 day after the medication was dispatched, Fisher Clinical Services was notified by the Courier that the delivery had been made successfully. The investigator site confirmed receipt of the clinical supplies at the right place and in the right conditions. The investigator site staff were able to accommodate the delayed delivery and the patient was able to take the required medication within acceptable timelines. The Logistics Team at Fisher Clinical Services had surmounted the challenges presented to them by this natural disaster in Chile.