A Local Full Service CRO in Argentina With Validated International Experience

We offer high quality front to end Clinical Research, Regulatory and Monitoring Services on time and under budget for local and international pharmaceutical companies.

Professional Service

Who We Are

Since 2009, a Full Service CRO with solid experience in all phases of Clinical Research, with dedicated attention to excellence, efficient communication and sponsor objectives, on time
and under budget

We have a Track Record in the successful conduction of Phase I-II-III trials approved for registration purposes by local (ANMAT), regional (ANVISA) and USA Agencies (FDA)

Our CRO also has solid experience in Phase I, Bioequivalence / Bioavailability and Early Phase Studies, Including First Time in Man, PK/PD, Food Effect and TQT Studies, audited and approved by FDA in June 2014.

In addition, we have full service experience in clinical and medical monitoring of pharmaceutical and device trials, senior project management, full regulatory and legal support, data management and statistics (EDC), quality assurance, medical safety and pharmacovigilance. These activities have been audited and validated with success by FDA in December 2019 for a trial conducted in Argentina.

Project Management and Quality Assurance

Dedicated, experienced team

Control of resources, procedures and protocols

Project management tools

FDA/ICH compliant standard operating procedures (SOP)

Ongoing training and help desk support

Full Regulatory Services

Legal Representation and Liability before ANMAT for Sponsors Outside Argentina

Preparation and submission of Regulatory Dossiers for Regulatory Approvals including:

Service Recipient Says

Oxmox advised her not to do so, because there were thousands of bad Commas, wild Question Marks and devious.

Kolis Muller NY Citizen

Oxmox advised her not to do so, because there were thousands of bad Commas, wild Question Marks and devious.

Kolis Muller NY Citizen

Oxmox advised her not to do so, because there were thousands of bad Commas, wild Question Marks and devious.

Kolis Muller NY Citizen

News & Blog

Behind the word mountains, far from the countries Vokalia and Consonantia, there live the blind texts. Separated they live in Bookmarks grove right

Clinical Trial Support

Regulatory Compliance

Monitoring

Audits

Vendor Management

Data Management

Electronic Data Capture

SAS programming

Randomization & IVRS

Data Standarization

Clinical Trial Support

Regulatory Compliance

Monitoring

Audits

Vendor Management

Data Management

Electronic Data Capture

SAS programming

Randomization – (IVRS)

Data Standarization

Get in Touch

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