Leon Research Clinical Research Services
We offer a wide variety of solutions that include all the activities related to the design, start-up and monitoring of clinical trials and research studies
CRO services
As a Contract Research Company (CRO) we offer solutions that include all the activities related to the design, start-up and following-up activities in clinical trials and research studies.
We can manage the whole process to introduce a new medical device or drug into the market, from medical writing to data management and registration.
Pharmacovigilance during the study and once marketing authorization is available.
Site Audit service or studies to ensure their correct performance and verify that the study documentation is in perfect condition and ready for a possible inspection or external audit.
We can also act as Legal Representatives for your clinical study in the European Union.
Pharmaconsulting Services
We can be your partner throughout the product’s life cycle until its introduction on the market, including the design of the investigation and the best approval strategy.
We participate in the definition and review of the study, along with all the necessary documents: Protocol, IB, IMPD and patient documents.
Registration to obtain the CE marking for medical devices, as well as support in the management of the Marketing Authorization dossier for the different procedures.
For authorized drugs, we support you with the registrations in RAEFAR/CESP, in addition to the management of fees and registration variations
Post-marketing pharmacovigilance. European QPPV and local QPPV in Spain, Italy and Portugal
Distribution warehouse
We have an in-house storage facility located in León (Spain) to import and store store throughout Europe Medicinal Products and Medical Devices coming from the clinical research in which we collaborate.
Our facilities are equipped with advanced technology for inventory processing, management, transportation and distribution, and fully compliance with all applicable regulations.
Experience
This is what we have done at Leon Research
16 years of experience and our work in more than 350 projects endorse us the expertise we have today
Projects with research drugs: phases I, II and III
Projects with Medical Devices
Projects with commercialized drugs
Projects with food supplements and cosmetic products
Top 10 therapeutic areas in which we work
We have the ISO 9001:2015 certification
Our activity is based on a quality management system certified by the ISO 9001 standard. we follow Good Clinical Practices (GCP) and the appropriate procedure (SOP) for each study León Research quality policy
What is your investigation project?
Clinical Study with Drugs
These are Leon Research´s services
We offer all the services associated with the clinical stage from the planning and design of the strategy to registration and marketing. The main advantage of working with León Research is that it can support you throughout this process, without having to change of partners, and the local knowledge and experience that we have developed in the countries where we work: Spain, Italy and Portugal
Leon Research can guide you on this path to define strategies that combine security, viability and return of investment.
Medical Devices studies and In Vitro Medical Devices
These are Leon Research’s services
The most important thing with a medical device is to have a company that knows the new regulation well (MDR 2017/745 and IVDR 2017/746) and can advise you on the regulatory strategy path to follow.
Studies for nutritional supplements
These are Leon Research’s services
In studies with food supplements, it is very important to have a partner who can advise and support you throughout the study: from the design of the study and the strategy to follow-up the analysis of the data and the final report.
After a meeting, our business development team prepares a detailed budget with all the tasks we think are necessary, as well as an estimated Gantt chart to know how long it will take.
We must keep in mind that the adherence of the participants in the nutritional supplement study is much lower than in a clinical trial and that the sites are not hospitals, so they are not as familiar with the clinical process.
We believe that the sites selection and the monitoring are two key elements for the quality and relevance of the data collected.
Studies for cosmetic products
These are Leon Researchs’ services
At León Research we offer solutions that include all the activities from the design and start-up of a study with a cosmetic product to data management and the final report or article.
To work together, we start with a meeting, after which we can prepare a budget with all the services detailed and with estimated timelines that include the time necessary for approval, recruitment, monitoring and data management.
In this type of cosmetic study, it is essential to select the right sites and their correct monitoring to ensure that the data is well collected, since the participants are usually less compromised than in a clinical trial.
We also offer Cosmetovigilance, essential to be able to follow-up after authorization.
Check out these posts about Clinical trials and CROs
Our way of working is different. Behind each task there is a person willing to achieve the success on the project
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