Clinical Research

Bearing very stringent regulatory requirements and high R&D costs, life science companies are increasingly seeking new places to outsource activities that can provide the necessary capacities to meet the stringent demands of research. In the selection process of these new places, companies assess a number of key criteria, including: regulatory framework, qualified human resources, scientific experience, technical skills, infrastructure, academy–company collaboration, research centers and health care centers such as hospitals and clinics.

Pharmaceutical companies tend to outsource Clinical Research services, involving scientists, regulatory agents, doctors and patients who participate in the research projects.

Such subcontracting is mostly done through Contract Research Organizations (CROs), specialized companies who manage clinical research outsourcing (drugs, medical devices and diagnostics). CROs must comply with strict protocols and must assure their customers (pharmaceutical and medical devices companies) and regulators that:

• Their clinical trials are conducted in accordance with acceptable technical standards.

• They comply with national and international ethical standards.

• Data is trustworthy and fraud-free.

It is estimated that there are over 1,000 CROs worldwide and that the sector receives approximately 30% of total global investment in R&D and bio-pharma.

Over 50,000 clinical trials are conducted annually and 40% are performed in "non-traditional" research locations. The industry is worth US$ 20 billion, with the top 10 CROs accounting for approximately 50% of total CRO revenue.

Clinical researches are also developed, led by groups of doctors who work in a coordinated manner focusing on different specialties, capitalizing on their experience and contact with patients in industry projects.

Uruguay currently is in condition to meet the demand for research projects due to the following factors:

• It boasts good basic training in medicine and research groups in specific diseases (study groups in hematology and cancer, among others).

• Health has historically been one of the areas of knowledge with the longest university tradition in the country, reaching 4.5 doctors every 100 inhabitants.

• Healthcare institutions accommodate patients with various diseases, thereby it is possible to carry out multicenter trials which require a reduced number of people. Consequently, the small number of inhabitants would not be a hindrance to develop the activity.

• Large innovative laboratories have commercial representation in the country and their interest in developing projects in Uruguay has been surveyed.

• The country has leading technology in the CUDIM, highly valued by pharmaceutical companies.

However, from a regulatory standpoint, times are still considered extensive by sponsors, a situation which is currently being worked on together with the MSP authorities in order to be adapted.

Map of major stakeholders