Through our investigation department and the medical team we offer our support to select the principal investigators and KOLs for each therapeutic area and warranty their commitment with the study.

We already have created links and laces with the investigators we have worked with, that let us count on with their confidence to reach the success on every investigation we take part, being them our principal prescribers

With this investigators database we could also help the sponsor to select the best sites all over Europe through our site selection system and database that ensure the feasibility of the services of the site (Pharmacy, Laboratory, Image Service, General Resources and Human Resources) according to the needs of the study.

We have a wide applied experience on the intermediation process between the internal regulatory affairs department of the sponsor and the government agencies and competent authorities (Local, Autonomic, State and European) to reach the approval of the different studies and trials, simplifying the whole process and reducing the costs associated to this activity.

We work and count on with and extend net of sites and their Ethics Committees, that allows us to warrantly the minimum consumption of needed resources to get the EC approval in each project we became involved

Necessary intelligence and creativity are applied on developing a global strategy which helps on saving resources to implant the medicine in the major markets possible, considering that a good global planning avoids duplicating efforts at the same time that simplifies the adaptation to the international standards to the specifics regulations of each country.

As a key factor on the development of any trial or study, we intermediate and provide legal advice in the negotiation of the contract between the Sponsor and all the vendors participating in the study, and help you to adapt it to the local regulations.

The development and monitoring process of each study, shows different needs on it, and in Leon Research we have an enough flexible structure to adapt our procedures according to them, maintaining the quality of the whole process untouched.

Through an extended relation with several sites and investigators in Spain, built up during the years of experience, we know how to optimize the resources and increase the profit of the investigators efforts adjusting them to the study objectives, warranting this way the utility of each invoiced hour.

We can help on ever activity for data planning and management involved on the development of clinical trials and statistical analysis for final study report and statistic report creation:

• Statistical analysis planning
• Sample Determination
• CRF detailed design and correction
• Data Base design and development
• Data Base Validation
• Data Entry (Simple and double)
• Queries Solving
• Data codification and encryption for confidential warranty
• Statistical Reporting

We understand Pharmacovigilance as the process of monitoring the safety of Development Medicinal Products (DMP), Authorized Medicinal Products (AMP) and Medical Devices, taking action to identify and evaluate adverse reactions to reduce the risks.

We provide a high quality PhV Service during each study by creating an specific planning for the safety system to be followed to each study adapted to the Good Pharmacovigilance Practice Guidelines included on the EU Legal Framework.

A huge amount of documentation is generated during each study and all local regulations requires to maintain it during several years.

We know better how to manage study documentation and we have fully equipped facilities to file during the study and to store study documentation at the end of it.

We count on with an archiving system that allows us to access to specific documentation in case of an audit or any other interest after the study.

We have also a procedure and system to review and complete quality check control of the studies that we have completed or studies that are being conducted by others.

This way we can ensure that the study and all documentation are in perfect conditions and ready for an occasional inspection from any regulatory authorities.

We have a team specialized in drug registration. We offer our experience in Spain, Italy and Portugal throughout the registration process in order to achieve your business success.