Jose Jimeno, CEO, VaxTRIALS
Jose Jimeno, CEOScientific research has evidenced diverse populations as a relevant factor in developing studies for vaccine trials, as the incidence of diseases is higher in certain groups. Latin America, one of the regions with great ethnic diversity, has easy access to a varied population that influences the safety and efficacy of a potential vaccine. Besides the demography, businesses and companies trying to establish a medical environment for vaccine trials are bound to be gridlocked by the complex modalities of life sciences. The lack of profound knowledge pertaining to the local regulatory, clinical requirements, and the vaccines’ time to market analysis has been some of the shortcomings of vaccine trials in the CRO industry. Contributing to the eradication of preventable diseases, VaxTRIALS with its comprehensive management has garnered expertise as a regional leader in streamlining vaccine research in Latin America. The company has been prolific with local regulatory knowledge in managing vaccine trials and reducing the time to market for drugs.

From selecting the appropriate trial sites with a representative patient population to ensuring fast turnarounds with local regulations, VaxTRIALS has been pioneering solutions designed to manage and monitor vaccine research across Latin America. The company focuses on optimizing the trial processes and its integration with robust and validated systems, automatically complying with industry standards. Alongside carrying out studies with a high volume of subjects, it provides external project support to clinical investigational sites in the development and decision-making processes of the trials.

“We participate from start to finish. This includes clinical trial design, protocol development, site identification, patient recruitment, clinical monitoring, clinical study reporting, and publication,” says Dr. Jose Jimeno, CEO of VaxTRIALS.

VaxTRIALS: Optimizing End-to-end Vaccine Trial Timeframes

With a data-driven patient enrollment approach as necessitated by study characteristics, enrollment goals, and timelines, it also optimizes clinical vaccine trial timeframes.

The company has contributed to the recruitment of more than 38000 subjects and 300000 study visits in association with leading investigators across the region. VaxTRIALS has been actively involved in developing 6 vaccines licensed thanks to their contribution. Dr. Jose Jimeno and his team have led the regulatory pathway in developing novel oral polio vaccine type 2. These regulatory pathways also aided major vaccine manufacturers in developing the COVID vaccine. Bolstered by such diversified experiences, VaxTRAILS has been involved in more than 45 vaccine-related clinical, epidemiological, and health economics trials, from which 9 were COVID studies including more than 22.000 subjets.

Our team at VaxTRIALS has profound local regulatory knowledge in managing vaccine clinical trials with agility and flexibility to reduce the time to market in vaccine clinical trials

In addition to overseeing outsourcing services required for vaccine trials in Latin America, VaxTRIALS provides site identification feasibilities, project management, monitoring activities, biostatistics, data management, and relevant services critical to vaccine trials. The company also caters to logistics, importation, the exportation of samples, and cold chain management prerequisites. Leveraging turnkey trial services, it retains an active presence in more than 10 Latin countries with investigational sites, the agility and flexibility of being local experts making it a key differentiator among its competitors. The company has exceeded expectations for clients, sponsors, and vendors with enrollment forecasting and a patient-centered approach.

Latin America has contributed, through the participation of more than 100,000 patients, to the development of 80 of the 233 vaccines prequalified by the World Health Organization (WHO). There are 26 vaccine-preventable diseases in Latin America, of which 23 are covered by WHO prequalified vaccines. Latin America has participated in development of 21 of the 26 vaccines (the five exceptions are the vaccines for tick-borne encephalitis, hepatitis E, rabies, typhoid fever, and Japanese encephalitis).