Karen Hahn
Director of Clinical Trial Management
View from the Top

Standarized Procedures Attract New Trial

Wed, 09/07/2016 - 12:37

Q: Mexico receives US$200 million in clinical research investment. Some believe this amount could triple within five years. How can this be accomplished?

 A: The government is modernizing its regulations. By analyzing the measures implemented by first-world markets, we can expedite clinical trial approvals without jeopardizing the quality of our products. The Federal Government, specifically COFEPRIS, learned that sharing local procedures in international forums can expand their understanding and improve efficiency in protocol approval. ICON is part of a CRO association that aims to standardize the segment’s processes. Rather than competing to retain new clients or businesses the market is collaborating to establish standardized procedures to attract new trials.

Q: How does the world perceive Mexico in terms of quality and infrastructure for clinical studies?

A: Pharma and Biotech client companies have increased trust in Mexico. The levels of enrolment have always been high but they are now supported by precise inspections performed by either the FDA or the European Medicines Agency (EMA). COFEPRIS has improved its own internal procedures leading to the emergence of Mexico as a world leader in vaccines. The Pan-American Health Organization’s (PAHO) recognition has opened the doors for Mexico. With ongoing audits by clients Mexico has proven capable of high quality. There are multiple opportunities that will advance our position. We can channel our energy and resources to studies that are affecting our community. In the past, we attracted whatever study fell in our lap but we must be shrewder. The government has asked us to attract studies that run parallel to therapeutic needs in the country like obesity, cancer and degenerative diseases.

Q: How does ICON decide which clinical sites it will do business with?

A: ICON’s internal system evaluates sites in Mexico based on available data. With it we can evaluate the site’s performance through metrics and forecasts. For instance, ICON has specific metrics around monitoring visits and the investigator’s engagement. The company is expanding its geographical outreach of sites and no longer focuses on large cities. We have found a niche in small towns that are accustomed to following our metrics, which shows the new found willingness of the market.

Q: With IMSS’ willingness to engage in clinical trials, what type of relationship does ICON have with this parastatal?

A: Over the past five years, ICON has conducted clinical studies with IMSS. But that is completely up to our clients. Although committing to IMSS takes time it is not impossible. Timelines are different, and so is the type of work that is conducted within the institute. Contracts may take longer to secure but the patient volume our clients have access to far exceeds any other clinical site. In addition, the number of specialists and therapeutic areas within the organization provides added benefits. Given its willingness to engage in these types of activities, IMSS is keener to comply with procedures previously established by CROs. The retention rate is also an advantage as patients are treated with the utmost attention.

Q: How is ICON incorporating new technology into clinical trials to transform the face of clinical research?

A: ICON combines best in class processes and industry leading technology, delivering impact and performance to its clients. Paper case report forms (CRFs) and clinical trial files are a thing of the past. ICON in collaboration with global pharmaceutical companies gained the eConsent accreditation through Firecrest, which will improve treatment compliance and expedite results in the near future.

Q: What goals has ICON set for 2016?

A: Growth is always in our sight. ICON’s Mexican operations are the largest in Latin America with almost 200 employees. Considering six years ago there were 40 employees, our systemic growth has been noteworthy. In 2016, ICON Mexico was awarded a large contract enabling the company to grow its staffing division by 45 employees. Historically, ICON Mexico has focused on phase II and III studies.