About Leon Research

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Principles

Intelligence and creativity

These two principles are key factor on scientist research, and we apply these two principles in all our work.

We put all the information and management intelligent systems at the service of our customers and we use creativity as the tool that can transform a project into a triumph.

Flexibility

It is our self-demand to have the flexibility to adapt our services to the client requirements, within the framework of the GCP/ICH and our own SOPs and quality system.

In a global word with global studies, we know better how to adapt to the local requirements

Honesty

Honesty is the main principle at León Research, it is our way of life. We understad it as trying to give others what you would like to receive: support, help, faithfulness, trust, tolerance and understanding.

Everyday job is based on hard work and mutual respect as the only way to achieve sucess.

Quality policy

The principles in which we support our working activity are based on a quality management system related to the ISO standards, in compliance with the ICH/GCP and the use of the best procedures in each study, and looking for the satisfaction of our clients.

GCP/ICH

We follow the guidelines of the International Conference on Harmonization (ICH) and the Good Clinical Research Practice (GCP).

SOPS

We provide our own Standard Operating Procedures or we may work with the established Standard Operating Procedures (SOPs) of each client with whom a contractual agreement exists to provide services for a project under the Client’s sponsorship.

Declaration of Helsinki

We work according the Ethical Principles for Medical Research Involving Human Subjects adopted by the World Medical Association on the Declaration of Helsinki and all its amendments.

EU Regulations

We apply the REGULATION EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use.

Spanish regulations

We apply the Spanish Law regulating clinical trials with drug, ethics committees and the Spanish Clinical Trials Register in the Royal Decree 1090/2015, the Orders SCO/256/2007, and SCO/362/2008, and the Circular Letters 07/2004 and 15/2002 from the Spanish Drug Agency (AEMPS).