Marlene Llópiz
CEO
CRO Mexicana
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Mexico Is Fertile Ground for Clinical Research

By Miriam Bello | Mon, 09/20/2021 - 15:03

Q: What does CRO Mexicana offer to the industry and how is its portfolio built up?

A: Clínica Responsable Operativa Mexicana, S.C. (CRO Mexicana) started in 1998 and offers a broad range of services for pharmaceutical companies, which are often overwhelmed by multiple tasks despite having large workforces and contracting secondary services to focus on their outcomes. Some companies prefer hiring partnering companies for clinical research because they require an unbiased, neutral third party to oversee and lead team members. The pharmaceutical industry sponsors studies and the contracted research organization (CRO) acts as a link between the company and the clinical sites that carry them out with expert principal researchers and specific patients.

Q: What makes Mexico an attractive country to conduct medical trials?

A: International trials depend on several factors, including short setup times to get studies up and running. After all, time is money. Mexico should not be considered as rescue country when a pharmaceutical firm requires patients with specific criteria to partake in a trial. Mexico should be a first choice worldwide from the start of any trial to actively be included from the get go and in parallel with other countries.

Mexico is an excellent place to carry out clinical trials for certain therapeutic indications, such as cancer, obesity, diabetes, heart problems and infectious diseases. The country has always been at the forefront and is again gaining ground in clinical trials worldwide. For a number of years, the clinical research arena had turned towards Asia, now returning to Latin America.

Q: How can Mexico become a key player in medical research?

A: Pharmaceutical companies have a pipeline of products being developed for several diseases and are always competing to bring new medicines to market. Mexico’s epidemiological profile includes a wide range of diseases of interest to pharmaceutical companies. The country is an adequate commercial partner for pharma firms to further explore their markets in Latin America. Nowadays, biotechnological firms should view Mexico as an outstanding marketplace for strategic business transactions.

From a commercial standpoint, the purpose of clinical research is to market medicines to a population requiring treatment. With a population of over 130 million people of all ages, pharmaceutical companies are keen to launch the medicines that Mexico’s population needs and requires. We have a wide range of pharmaceutical companies in Mexico, making the country an excellent destination for clinical research. It has patients, well-prepared researchers, sites, CROs and pharmaceutical companies to propel clinical research and bring novel treatments for patients.

Q: What part of the population is more involved in clinical trials? Do women have lower participation, for example?

A: It depends on what the clinical study is about. Each clinical trial requires patients with specific ailments, of different ages, sex, with certain characteristics. For instance, seniors are not commonly involved in clinical trials because most of them have co-morbidities that limit their participation. It is also difficult to find a large population over 60 years old who does not take any medication, which also automatically may exclude them from trials. Every clinical trial has a set of criteria for including or excluding patients. The more ill a patient is and the more co-morbidities he/she has, the higher the likelihood they will be excluded from a clinical trial. We seldom see geriatric trials per se. Trials are directed at diseases and therapeutic indications. If a patient meets the criteria, he/she is asked to take part in a trial.

Women often participate in clinical trials depending on the trials´ requirements. Male patients have a greater propensity to certain diseases, which is why on occasions they participate more meeting the required criteria. Women participate specifically in trials on ovarian and breast cancer, in addition to trials on diabetes and other illnesses.

Q: How did the pandemic hit CRO Mexicana and what do your expansion plans look like?

A: The pandemic has pushed us back slightly but we remain focused on expanding to California and Florida. We have scheduled meetings with universities in the US and clients. We also plan to expand to the EU. Trials have been slower than usual but we have been focusing on medical research, medical writing and advisory boards with key opinion leaders. We also incorporated a patient-centricity division, as well as a psychology department which actively participates in patient focus groups and timely support groups within our company.

Q: What makes CRO Mexicana the best solution for its clients?

A: CRO Mexicana is a virtual partner to pharmaceutical companies. We work alongside these companies and in a very short time become shoulder-to-shoulder team members. We work with different kinds of companies, government health institutions, insurance agencies, universities and NGOs from Central and South America to perform trials in Mexico. We can be the MSL or virtual manager that takes the load off the companies’ back thanks to our expertise and specialized staff. We are on time and in line with company strategies and budgets. For pharmaceutical companies, we are your CRO and business partner in Mexico.

 

Clinica Responsible Operativa, S.C. (CRO Mexicana) has over 20 years of experience in the US, Mexican and Latin American markets working with pharmaceutical companies in conducting clinical trials, active clinical research, regulatory affairs, developing advisory boards with KOLs in several therapeutic indications, patient focus groups, continued medical education courses and training, translations, medical writing, and the establishment of international strategies.

Miriam Bello Miriam Bello Journalist and Industry Analyst