Ciro García
Director General
Accelerium
/
Insight

Mexican Edge in Clinical Trials

Wed, 09/07/2016 - 12:41

The development process of innovative pharmaceutical and biotechnological products is widely known to be long and expensive. Time scales and costs are extensively documented and identified in multiple industry analyses. According to Bain & Company, these costs range between US$900 million and US$1.7 billion. Discovering and commercializing a new medicine takes an average of 10- 15 years. As the pharmaceutical industry’s profit margins are subject to increasing pressure, biotechnological and pharmaceutical laboratories turn to outsourcing for many aspects of their growth strategy. This pressure is predicted to rise in the near future. Contracted research companies together with clinical testing centers are taking on greater importance and have become strategic associates for the biopharmaceutical industry to protect profit margins.

Clinical trials play an increasingly critical role in light of a growing number of procedures and in the complexity of investigation protocol. Testing now requires a more diverse mix of patients globally but within specific criteria. These factors continue to push testing globalization, resulting in the solidification of these trends and inevitable geographical dispersion.

In the past, clinical trials were principally carried out in the US. However, high demand for trials and insufficient access to patients led the biopharmaceutical industry to look to other regions. The demand for research services in Mexico is an overriding tendency, largely thanks to COFEPRIS’ interest in positioning Mexico as a global leader in the industry. Formal training programs for medical researchers also contributed to this trend.

Centers for clinical investigation that have the adequate infrastructure and human capital that is qualified to manage clinical studies effectively will be a key element for the success of R&D. The ideal research center provides necessary resources to carry out these studies in line with internationally established guidelines. Accelerium Clinical Research’s services understand the clinical investigation phases through access to large groups of patients and skilled medical researchers, operating under the strictest parameters of quality management, standardized procedures and the rules stipulated by the International Conference on Harmonization (ICH) and Good Clinical Practices (GCP).