LEON RESEARCH, S.L. of León at MEDICA 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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LEON RESEARCH, S.L.

C/ Nicostrato Vela, S/N, M11.2 Parque Tecnológico León, 24009 León
Spain
Telephone +34 987 261064
Fax +34 987 216243
info@leonresearch.es

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Hall map

MEDICA 2021 hall map (Hall 15): stand K19

Fairground map

MEDICA 2021 fairground map: Hall 15

Contact

Marga Blázquez

International Business Development

Phone
+34 638818590

Email
mblazquez@leonresearch.es

Sara Lopez

International Business Development

Phone
+34 626864980

Email
slopez@leonresearch.es

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Our range of products

Product categories

  • 07  Medical services and publications
  • 07.10  Consulting services for health organisations

Our products

Product category: Consulting services for health organisations

Medical Affairs

We provide value within the drug life - cycle, covering patients´ needs. Among the Medical Affairs services that we offer:
1. Medical Writing:
- Publication plan & evidence creation
- Regulatory strategy: Dossier/Regulatory Documents
- Slide kits or revision of slide kits
- Pharmacovigilance reports
- Bibliographic research
- Coverage in Congresses, Symposiums and scientific meetings
- Content creation for e-health web pages.
2. Scientific Meetings support:
- Advisory Boards
- Scientific Expert Meetings
- Focus Groups
- Investigator Meetings
- Expert meetings
- Scientific Leaders Forums
- Scientific Congress Booth content
3. Medical Education: Internal and external training
- Pharmacovigilance values
- Regulatory values: Drug/Medical Device/Cosmetics
- Clinical Investigation Methodology
- RWE and evidence creation
- Biostatistical Principles
- Good Clinical Practices
- Investigational sites training

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Product category: Consulting services for health organisations

Pharmacovigilance

  • We have 6 years of experience in Pharmacovigilance services
Main experience:
• QPPV and local QPPV representative for several radiopharmaceutical products
• Local QPPV representative for European MAH in Spain, Portugal and Italy
• Literature researches and PSMF creation and maintenance for radiopharmaceutical products
• Pharmacovigilance from early stages (Clinical Trials)

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Product category: Consulting services for health organisations

Drug and Medical Devices Registration

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

Main experience:
•MAH representative for several radiopharmaceutical products registered in Spain (national
phase of variation procedures for authorized products by decentralized and mutual
recognition procedure)
•Application of authorization of use for an advanced therapy (national authorization)
•Marketing authorization application for an orphan drug under centralized procedure
•Consulting activities for Scientific advice and ITF briefing meetings procedures

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Product category: Consulting services for health organisations

Full-service CRO in Spain, Portugal and Italy

Leon Research is a CRO company that offers outsourcing pharmaceutical services across Europe to the pharma industry, Biotech companies, Medical Devices manufacturers, the Food industry and other CROs. Regarding our experience, we have developed more than 300 clinical trials from phase I to IV, Medical Devices Studies, observational studies and food supplements in the following areas:
-Opthalmology
-Oncology
-Neurology
-Cardiology
-Endocrinology and nutrition
-Rare Diseases
-Dermatology
-Autoimmunity
- General Surgery
-Infectious diseases
- Paediatric
-Traumatology
-Haematology
- Allergology
-Gynaecology and many other areas.

Among the services that Leon Research offers as CRO, it should be highlighted: the design, the setup and the monitoring of clinical trials and the investigational study, also providing services of data management, biostatistics analysis and medical writing. Furthermore, we cover the process of introduction of a new drug into the market, offering services of pharmacovigilance and drug/medical device registry in the regulatory organizations.

Our compromise in each study implies fluent communication with clients and sites, adaptability and flexibility to adapt to client needs and efficiency, always following high-quality procedures.

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About us

Company portrait

The company was founded in 2007 in Spain. Our main headquarter is located in León (Spain) but we also develop our activity in Italy and Portugal with our own staff. 

The services we provide are:

- CRO Services for clinical studies: definition and design of medical studies, site selection, Regulatory and EC submissions, contract negotiation, monitoring of clinical studies, data management, biostatistical analysis,long term archive and Clinical auditing. Mainly by our own team, except for biostatistical analysis which is always hired by our external vendor. In Data management we collaborate with third parties. We provide this services in Spain, Italy and Portugal and through AICROS (an alliance of international CROs we are part of) in the rest of Europe, Israel, Australia, United States and Canada.

- Registries: preparation of dossier for registration of pharmaceutical products and medical devices. By our own team.

- Pharmacovigilance: Local and European representation services for Pharmacovigilance (QPPV and LRPV). By our own team in Spain, Italy and Portugal.

- Medical affairs: medical writing, market access, medical education and medical advertising. By our own team and with third parties.


We have 14 years of experience, we have worked in more than 300 studies in 900 sites (Spain, Portugal and Italy).

We have a wide experience in clinical trials (all phases), non interventional studies studies with medical devices and other type of studies like nutritional studies.

Company information as a PDF file