VaxTrials
Conducting Clinical Trials through an End-to-End Approach across Latin America

A competitive timeline for regulatory approval processes and access to cost-effective and high-quality investigational sites are felt and shared needs by pharma and biotech companies across the globe. These companies require a specialist who understands the local regulatory environment and deals with clinical processes to successfully conduct their clinical studies.

VaxTRIALS, an expert CRO in the LATAM region, helps these companies manage their clinical trials and deliver high-quality results for their clinical development programs.

The company has performed more than 50 trials over the decade in this emerging region with high disease incidence rates and a vast and diverse patient population. It provides pharma and biotech companies of all sizes with a broad portfolio of clinical trial services for different types of research. This includes interventional phase I-III clinical trials, observational / non-interventional studies, RWE, IIT, post-marketing authorization studies.

VaxTRIALS’ end-to-end approach includes:
● Project feasibility assessment
● Site identification
● Selection and management
● Strategic planning, protocol development
● Logistics, supply chain, clinical monitoring,
safety and medical monitoring
● Pharmacovigilance
● Medical writing
● Statistics
● Data management
● Ethical and regulatory submissions
● Overall project management

Its high-performing teams, capable of delivering high-quality results in a complex environment, offer results-oriented solutions for the challenges faced during trial implementation. They are well-versed with clients’ concerns related to subject populations, disease incidence rates, vaccination coverage indicators, medical and scientific questions, and data quality. Their immense expertise and scientific and technical knowledge allow sponsors and investigators to properly deal with issues that arise before and while conducting the study.

The combination of an experienced team, a robust clinical quality system, operational procedures, and a solid project management structure take the load off clients’ shoulders. VaxTRIALS’ regional regulatory team understands regulatory frameworks and has the ability to handle communications with the competent authorities of the LATAM countries. This complete set of abilities enables them to seamlessly handle the entire process while navigating the unpredictability and uncertainty involved in trials and their related regulatory approvals.

“Our solid knowledge of the local context and regulations allow us to reduce the trial implementation time.” says Tom Herremans, CCO, VaxTRIALS.

VaxTRIALS is a lean organization that enables clients’ direct access to leadership at any point in the study. This flexibility and agility are reflected in its study's recruitment needs and process as well. Recognizing that participants’ motivation plays a key role in the trial’s success, VaxTRIALS has designed a patient-centric methodology for recruitment. It employs a data-driven enrolment approach based on study characteristics, recruitment goals, and timelines to ensure the selection of the right population size and demographics. Promoting faster patient enrolment and higher adherence throughout the studies optimizes clinical trial timeframes and expected outcomes.

As evidence of this, VaxTRIALS helped a mid-size Europe-based pharma company complete their phase I trials in Latin America. Results of first-in-human clinical trials for their new vaccine were critical for continuing their product and clinical development program worldwide. Solid project management structure and outstanding processes for regulatory activities, site management, clinical monitoring, and quality management helped the client successfully continue their clinical development.

VaxTRIALS also participated in developing a novel candidate norovirus vaccine that could be a new pillar in preventing illness and hospitalization of children due to acute gastroenteritis. It has enrolled around 3,500 participants by implementing the synergy between preferred highly qualified sites and a special strategy for recruitment and adherence. For executing the phase 2B study and identifying acute gastroenteritis events (AGE), the company created a special case reporting system with its partner in clinical systems solutions, the medical department, and the process improvement unit. This solution increased the detection of cases by 40 percent and ensured sample collection to meet efficacy analysis endpoints.

VaxTRIALS has been involved in many other clinical, epidemiological, health economics, and environmental trials and has helped many clients, sponsors, and vendors achieve extraordinary results.

“We have a high degree of specialization in specific diseases like Chikungunya, COVID-19, Influenza, Dengue, Hepatitis A, Meningitis, Norovirus, Norovirus EPI, Herpes Zoster, Pertussis, RSV, and Polio, to date,” says Jose Jimeno, CEO, VaxTRIALS.

VaxTRIALS is a small-sized CRO that continually adopts the latest technologies, techniques, and tools in clinical research. This helps them remain competitive and offer a range of value-added solutions for clients’ needs. Its structure provides individualized attention at every step by a dedicated staff, without the usual constraints of huge overhead and layers of bureaucracy in bigger CRO firms.

“Our size, structure, specialization, and organization enable us to provide every client with the same attention and exceed the expectation of meeting the critical needs of their specific fields and areas of drug development,” says Jimeno.

VaxTRIALS has shown solid, stable, and flourishing corporate finance indicators and company results. Clients’ confidence in VaxTRIALS and its experience and strength drive this growth for the company, making it a leading CRO expert in LATAM.

BREAKING NEWS: on Oct 5th, Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announced the acquisition of VaxTRIALS.