Karen Hahn
Program Director
View from the Top

CRO Turns 20, Contemplates Its Role in the Region

Wed, 09/05/2018 - 14:17

Q: What actions is ICON taking to strengthen its position as a CRO in both Mexico and Latin America?

A: This year, ICON celebrates 20 years in Latin America, a region in which it has about 535 employees. Of these, 210 are in Mexico, which makes the country our largest office in the region. This year, we will focus on strengthening our business in Latin America through the development of new research areas and clients.

In Mexico, we are fully aligned with the epidemiological changes the country is facing. We have analyzed the National Health Plan to target the priorities of each presidential administration in line with the epidemiological changes of the population. We have also shortened our internal times and invested significantly in employee retention.

Q: Mexico has significant potential to become a hub for clinical trials. What is needed to achieve this goal?

A: Many initiatives are being developed to strengthen clinical trials; we just have to nail them down. For instance, many steps have been taken to promote collaboration with IMSS but there are still obstacles to successfully work with the institution. Another problem is that although the government has made a strong effort to open several centers that pass preliminary judgment on clinical trials for medicines and medical devices, called Unidad Acreditada de Apoyo al Predictamen (UHAP), only a few are fully functional. This initiative was so good that it is now being implemented in other Latin American countries, but implementation challenges have limited its function in Mexico.

Q: How can the clinical research industry’s collaboration with IMSS be improved?

A: IMSS’ internal bureaucracy has been problematic and the rules for paying the institution have not been well defined. IMSS clinics and hospitals located outside of Mexico City must also be incorporated into this collaboration scheme; butat the moment, other states and their patients are staying out of this initiative. Innovation should be accessible to all citizens, not just to those who live in a large city. Working with other states will also grant us access to patients who present diseases seen only in specific regions.

Q: What can CROs do to strengthen clinical trials in Mexico?

A: Both pharmaceuticals and CROs should be open to working with new research sites, since we often stay with the same one for too long. It would also be good for research sites to create their own organizations or associations to work on their shared goals. This network could help research sites to better distribute their work among each other to avoid saturation at sites in demand. All CROs work with more or less the same research sites. Furthermore, most research sites are located in major cities. It would be beneficial for CROs to bet on new sites and doctors who are willing to learn the minutia of clinical research.

Q: How can technology benefit patients and facilitate clinical trials?

A: Electronic medical records have been under development for a long time, but they have yet to materialize in our country. The existing health regulation grants patients full access to their clinical record but they are not given any information when they leave an institution. These records could be shared among health institutions following the strictest security measures.

Q: What agreements is ICON creating with public and private organizations to improve clinical trials in the country?

A: Alongside ACROM and AMIIF, we have participated in the revision of several regulations, including the General Law of Health and those concerning pharmacovigilance. The existing legislation is too old. The goal is to update it to tackle today’s needs in terms of employees, technologies and processes. The sector needs transparent regulations in accordance with international standards.