Cecilia Moreno
Head of Clinical Operations
View from the Top

Outsourcing Clinical Research to Drive Competitiveness

Wed, 09/09/2015 - 09:24

Q. How seriously is the CRO industry taken as a sector in its own right in Mexico?

A: CROs play a significant role within the clinical research (CR) industry in Mexico and all over Latin America, mainly due to the general trend of outsourcing CR services. In Mexico this is partly a result of the integration of the local CRO industry association in ACROM, and its important role in interacting with the industry and the regulatory authorities such as COFEPRIS. In the coming years, the CRO industry, as a recognized sector, will keep on acting as a consolidated driver to promote the competitiveness of Mexico.

Q: In spite of its strengths, only 1.2% of global trials are conducted in Mexico - how can this be improved?

A: In general, all of Latin America has the potential to increase its participation in the pharmaceutical research market. As an emerging country, Mexico still needs to develop and regularly promote its advantages, such as its geography, population, epidemiology, economy and medical infrastructure. The three most important factors in which all stakeholders are working together are the improvement of professionalization of clinical sites, the implementation of a more efficient regulatory process to approve clinical trials, and finally the encouragement of greater collaboration among academia, regulatory authorities and the industry. Working in an integrated manner within the region will also help to increase its competitive position in terms of country mix determination and resource optimization.

Q: What role does the PPD office in Mexico play locally and regionally?

A: Mexico was the third office PPD opened in Latin America in 1999, after Brazil and Argentina, in response to the growing potential of the region. During the last 15 years, PPD’s main role in Mexico has been to support the global and regional business through using the highest quality standards. In the local market, PPD has been building a solid image with strong and proactive participation in most of the local CR forums. In Mexico we have always been responsible for clinical operations conducted in Central America and the Caribbean, and since 2014 we have been part of PPD’s Northern Cone of Latin America, which includes Colombia, Ecuador, Peru, and Venezuela. This structure offers us the opportunity to optimize resources and expertise within the region and boost our delivery features to the benefit of our clients. The Northern Cone is augmented and balanced by the Southern Cone, which is comprised of Argentina, Brazil, and Chile.

Q: Recently IMSS opened to clinical trials – are you hopeful this will incrase clinical trial levels?

A: IMSS and has an impressive infrastructure, with almost 2,000 medical units nationwide, of which 36 are third-level hospitals. In 2013, IMSS provided more than 125 million office visits, which equates to more than 350,000 a day. Over the past ten years, few companies have conducted clinical trials within IMSS, but this new direction is now opening the possibility to conduct pharmaceutical studies in its facilities. This openness should be considered as very positive, with the hope of substantially increasing Mexico’s potential to compete for large global and regional trials.

Q: What is your perspective of Mexico as a platform for managing more clinical trials?

A: Latin America is attractive to global investors given its large population, and wide accessibility, among other factors. Under these circumstances, Mexico currently has a great opportunity to become the regional leader in CR due to its current positive macroeconomic environment and open regulatory position. There is a general effort in Mexico to replicate as much as possible the proven successful Korean model (Korean Network for Clinical Trials, KONECT), which may help growth.

Q: How do the ongoing delays in approving and opening new protocols impact CROs?

A: The average clinical trial approval timeline in Mexico, about six months, can be considered competitive when compared with other Latin America countries. However, it is widely recognized that there are still many key development areas that must be addressed. COFEPRIS is actively proposing ways to enhance the efficiency of its internal processes, to address the approvals backlog. They are also requesting the industry help with the process by holding meetings to discuss all pending approvals and collectively reviewing all the relevant information, and so far this strategy has been effective.