Services

Clinical Trials

AVANTI ARO Services

AVANTI ARO provides a range from academic leadership, cooperation agreements with universities in the USA, Canada, Europe, Australia and Latin American countries, to full-service clinical trial management capabilities, a perfect blend of ARO and CRO, including site monitoring, data management, statistical analysis, safety monitoring, and clinical events classification, in addition to clinical expertise.

The Avanti ARO services cover all steps of a clinical trial with consistency reducing timelines and costs, such as:

Development of clinical protocol , Phase I to IV and RWE

Design, development, of CRFs and eCRFs platform

Monitoring

ICF development in compliance to international and country regulations

Selection of sites, staff training

Close interaction and selection of vendors/partners such as central lab, image lab, IVRS, etc

Development of study related materials to sites, pharmacy manual, advertisement materials etc

Investigator Meeting organization

Technical translations

Creation and submission of regulatory packages and dossiers for Regulatory approvals

Regulatory Ethics approval and follow-up during the whole study duration

Medical Support , case management, SAEs, SUSARs, hotline 24/7

Development of database and statistical services

Clinical Supply Chain

Importation and Exportation

AVANTI provides trading expertise, including customs (import/export) clearance, and specialized service focused in the regulatory requirements in Brazil and Argentina.

Controlled Storage (Room temperature, Refrigerated, Frozen and Ultra-low Temperature)

Our facilities and services comprise a wide range of storage conditions for products throughout the life cycle of a clinical trial, to accommodate the storage and logistic demands of each project.

Inventory management

AVANTI controls and verifies all randomization codes used in clinical trials to ensure that each supply is uniquely identified, that inventory control is consistent and up-to-date, and that the integrity of the blind can be maintained.

Distribution

Our customers rely on our distribution capacity and in the monitoring systems used throughout our cold chain network. We offer a variety of cold shipper solutions including validated transportation box systems and temperature monitoring devices. With our end-to-end support capabilities and partnerships with leading couriers we offer service excellence, promoting satisfaction to research sites and sponsors.

Labeling

We offer primary and secondary labeling and re-labeling services, we provide Clinical Booklet Labels and Conventional Clinical Labels, available in a variety of configurations and languages. Considering the consequences of inaccurate labeling, all precautions are used to ensure the accuracy of our services.

Comparator product and Ancillary Supply Sourcing

AVANTI provides to our costumers an efficient way to outsource product management through a wide network of experienced vendors, agile in supplying products to Brazil and Argentina.

Agility being one of AVANTI’s main differentials, our flexible and experienced team meet the needs of our customers and projects providing access to products and ancillary supplies in order to avoid delays in project conduction.

Reverse logistics (exportation) and destruction

AVANTI offers the reconciliation, return/collection, destruction and exportation of drugs and products used in clinical trials, customizing our services in order to meet our customers and projects needs. We value our customers and the success of their projects, and therefore planning is essential when it comes to inventory, returns accountability, reconciliation and destruction of clinical trial products.