Mexico1

“High research costs and falling patient enrolment numbers are factors which have greatly influenced the continued globalization of clinical trials, with many multinational and biotech companies targeting developing and emerging countries for clinical research. One of the most popular LATAM countries for clinical trials at present is Mexico due to its high population, its strategic location near North America and its stable economic and political status since the 1993 NAFTA (North American Free Trade Agreement).

Fisher Clinical Services Mexico was established in 2008. We provide a breadth of services at local level, from importation to secondary packaging, comparator sourcing, labeling, storage and distribution, all the way through to destruction. We invite you to find out more about our facility.”

 

Nora Hernandez, Country Manager, Fisher Clinical Services, Mexico

Fast Facts on Mexico and the Healthcare Industry:

  • Mexico is the world’s 9th largest pharmaceutical market
  • Mexico has the 2nd largest population in LATAM and Mexico city is the most densely populated city in the world
  • Mexico is the 2nd country that conducts the largest number of clinical trials in Latin America. Argentina and Brazil are other popular LATAM countries for clinical trials.
  • Mexico has a high percentage of the adult population not previously involved in clinical trials – ideal patient recruits for trials on Alzheimer, Parkinson, osteoporosis, cardiovascular and rheumatoid illnesses
  • The regulatory entity in Mexico is COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios)
  • Many clinical trial studies are submitted by institutions, such as large hospitals, in representation of pharmaceutical companies and biotechs that do not have a presence in this country

 

Mexico-about

Nine years of dedicated experience in clinical supply distribution to sites

Mexico City Fast Facts:
Location: Central Mexico
Population: 122.3 million
Nearest Airport: Mexico City International (MEX)
Distance from Airport(s) to Facility: 7 Miles
Fun Facts: Mexico introduced chocolate, corn, and chilies to the world

City:
Mexico City, Distrito Federal
Country:
Mexico
Opened:
2008
Total Capacity:
1,498  m2
Secondary Rooms:
2
Cold Production Rooms:
1
Warehouse Capacity:
7, 109 m3
Refrigerated Storage Capacity (2-8):
1,154 m3
Frozen Storage Capacity (-20):
36  m3
Controlled Drug Storage Capacity:
192 m3
Environmental Technologies:
Yes
Audited:
COFEPRIS
Comparator Sourcing:
Yes
Returns & Destruction:
Yes
Labeling:
Yes

Mexico-benefits

Key Benefits for Sponsors:

  • Strategically located in central Mexico – 12.6 Km from Mexico City International Airport (MEX)
  • A state-of-the-art cGMP compliant facility, audited by COFEPRIS
  • Fast customs clearance of IMP according to law 3.1
  • Secure storage with biometric security access
  • Designated storage area for controlled drug only
  • Cold chain expertise in storage, handling and distribution of temperature sensitive products
  • Comparator sourcing, protecting against counterfeiting
  • Local materials manipulation, e.g. Labeling capability
  • Full regulatory support & guidance
  • Distribution & Logistics model to realize cost and performance efficiencies
  • Certified returns & destruction service
  • Supported by other Fisher Clinical Services cGMP facilities in the LATAM region

Multinational Sponsor selects global player to handle high risk product for clinical trials

Expert in handling high risk product for clinical trials

A multinational Sponsor needed to choose a reliable provider with a wealth of expertise in delivering highly complex products from point of origin to patients at investigator sites, on-time and in perfect condition. Fisher Clinical Services Mexico was chosen to provide the distribution and logistics services needed to successfully handle and transport its controlled drugs (PICSC) across the supply chain to investigator sites in Mexico.

COFEPRIS The team at Fisher Clinical Services, Mexico worked closely with COFEPRIS – Comision Federal para la Proteccion contra Riesgos Sanitarios – to ensure the smooth running of the Sponsor’s clinical trials. All directives, regulations and guidelines issued in relation to the handling of all medication containing controlled drugs were adhered to. In this instance, Fisher Clinical Services acquired all the relevant approval documents and authorization certificates needed to release clinical trial materials to our state-of-the-art facility in central Mexico City within 1 day of their arrival into customs.

Distribution Model The distribution options across Mexico are immense, with over 1724 airports and a network of over 132,000km throughout the country. The Fisher Clinical Services team worked with the Sponsor to fully accommodate the unique requirements of its trial and to define a distribution model that would meet its needs. As this Sponsor was targeting a large number of patients in Mexico, there was a requirement to distribute clinical trial materials at scheduled times to investigator sites located in the city and also in remote locations.

Since its establishment in 2000, Fisher Clinical Services has developed close working relationships with international and local logistics service providers. For the purposes of this clinical trial, all approved couriers were evaluated and the best couriers were chosen for each specific route, realizing cost and performance efficiencies and mitigating risk across the supply chain,

A distribution model was defined and scheduled to ensure the delivery of adequate supplies to investigator sites at all times, On-Time, In-Full and in the right conditions.

Cold Chain compliance The Sponsor wanted to ensure that all temperature sensitive clinical supplies would not be compromised in any way, either in storage or in transportation to the investigator site. Fisher Clinical Services conducted a risk analysis study in advance of the trial to eliminate potential risks across the supply chain.

The Fisher Clinical Services Mexico facility was chosen by the Sponsor due to its Good Manufacturing Practices. Additional security measures were put in place with back-up generators at the facility on stand-by to accommodate power outages, thereby ensuring temperature compliance, whether ambient, refrigerated or frozen, at all times.

Track and Trace All clinical trial materials were carefully packed in appropriate shippers for secure transportation across the supply chain at the right temperature. In addition, Fisher Clinical Services carefully scheduled delivery times to accommodate opening hours at the investigator sites, especially for those located in more remote areas. All shipments were tracked and traced and closely monitored by the Global Logistics Helpdesk team at Fisher Clinical Services. Any alerts activated to highlight potential temperature excursions along the route to the investigator sites were pro-actively addressed to achieve a 100% On-time, In-full delivery of all clinical materials in perfect condition.

Control and visibility As this clinical trial included high risk products, the Sponsor wanted to maintain visibility of its inventory at rest and in motion across the supply chain. To this end Fisher Clinical Services Mexico provided the Sponsor with direct access to its inventory stock information via a secure web portal. The Sponsor was able to review its stock inventory at any time, and to generate reports without having to engage with the team at Fisher Clinical Services Mexico.

Other Studies Fisher Clinical Services Mexico continues to provide support to multinational and local pharmaceutical and biotech companies from importation to secondary packaging, regulatory support, comparator sourcing, labeling, storage and distribution, all the way through to destruction.