Annette Ortiz
Director General
Epic CRO
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Insight

Local Expertise Enhances Customer Satisfaction

Wed, 09/07/2016 - 12:29

Two years ago EPIC CRO was created to entirely focus on Latin America, though it already had nine-years’ experience under its belt. In 2001, global regulatory requirements for clinical research were easier to comply with but now each regulatory agency faces different challenges, representing an opportunity for local CROs. EPIC CRO has capitalized on Mexico’s evolving position in the global pharmaceutical and clinical research industry through its local expertise. “I am proud of Mexico’s current position as the second largest pharmaceutical market in the region, and its regulations are following international standards,” says Annette Ortíz, Director General of EPIC CRO.

Efficient and supportive regulation has been key to improving Mexico’s competitiveness internationally. Now that the country has world-class regulation for biotechnology drugs Ortíz is confident clinical research will grow. Other countries in Latin America are developing independent regulations hardly aligned to international standards, while others are completely lacking. Both situations are not desirable since companies want their products to be protected by intellectual property laws and entering those markets could represent a risk. Excessive regulation could also deter product entry into domestic markets. “I would say Mexico is in the middle,” says Ortíz. “The regulation is clear and has proven to support the industry. Therefore, companies are prone to bring more clinical trials to the country.” Mexico’s proximity to the US is also a benefit since they share time zones, which facilitates clinical trial logistics and sample and supplies shipping.

Ortíz believes companies need to understand Mexican regulatory requirements for pharmaceuticals for clinical research investment to potentially triple. New molecules, combination drugs, generics and biopharmaceuticals all require different registration processes and clinical trials. Companies also have to be realistic about timelines – the submission process of a new study protocol can take three to six months. “When a company manages to fully understand the regulation and prepares submissions correctly it is closer to a successful product launch,” explained Ortíz. “Some people believe that complying with the regulatory package in Mexico is very easy but in fact companies need to plan ahead and consider the time it will take to undergo the whole development and registration process.” Risk management tools are effective in identifying milestones and they provide excellent data for strategic planning.

According to Ortíz, a case-by-case analysis is done to fully understand client needs. “We focus on several things such as the protocol design, the experts who will be conducting the study, the regulatory strategy to follow and of course the budget,” she says. EPIC CRO strives to have customized services not just for the company but also for each product, which is the secret to its success. With a Clinical Trial Management System (CTMS) in place, the company is able to manage the progress of all its studies.

There are several advantages for small local CROs. “While large international CROs are oftentimes more expensive than smaller local ones,” says Ortíz. “They often look for local partners because either they do not have the expertise in a particular area or have huge workloads and limited resources.” Therefore, clients often negotiate directly with small CROs, which provide local expertise and excellent customer service, making value delivery and customer satisfaction easier. In addition, clinical trial management is easier, more direct, and faster, increasing customer trust. Small CROs have less rotation and more employee loyalty, which is highly cherished. However, they also look for CROs with complete infrastructure so limited technology remains a challenge. When it comes to budget allocation large CROs have the advantage of being able to subsidize small trials with larger ones.

EPIC CRO aims to increase the amount of clinical trials it manages and become one of the top CROs in Mexico. “We will be focusing on that over the next three years and at the same time we will further increase our capabilities in Brazil, Argentina, and Colombia so we can become a stronger clinical research player in the region,” explains Ortíz. EPIC CRO will expand its technological capabilities and is determined to stand out for clinical trials management service and risk control. With quality being a high priority for all the staff, it is aiming to provide better services than larger CROs. “As a local CRO we provide scientists and professionals with opportunities to develop their careers and I am proud to say we employ 20 Mexican professionals now,” says Ortíz.