COMPANY
CRO AND PHARMACEUTICAL CONSULTING SERVICES IN SPAIN, ITALY AND PORTUGAL
https://leonresearch.com/es/inicio-leon-research-ensayos-clinicos-espana-italia-portugal/
https://leonresearch.com/es/inicio-leon-research-ensayos-clinicos-espana-italia-portugal/
DESCRIPTION
We are a CRO and pharmaceutical outsourcing company based in Spain, Italy and Portugal. We offer support throughout the clinical process from study design and planning, monitoring, statistics and data management to registration for the subsequent commercialization of an investigational product or medical device. We also offer support in pharmacovigilance and post-marketing surveillance. Over 15 years of experience, we have participated in more than 350 projects in the field of clinical research, mainly for the pharmaceutical and medical device sector and also for national and international developers in the biotechnology and food sector. Main services: • CRO (Contract Research Organization). • Pharmaceutical consulting: registrations and medical affairs • Pharmacovigilance • GCP audits of clinical sites • Warehouse and distribution
SERVICES
01/06
CRO (ORGANIZACIÓN DE INVESTIGACIÓN POR CONTRATO) PARA MEDICAMENTOS, PRODUCTOS SANITARIOS Y SUPLEMENTOS ALIMENTICIOS
Planificación y diseño
Redacción médica
Selección de centros
Aspectos regulatorios (presentación a comités éticos y Agencias reguladoras)
Negociación de contratos
Monitorización
Gestión de datos
Bioestadística
Archivo de larga duración
Control de calidad
PHARMACEUTICAL CONSULTING FOR REGISTRATIONS
Consulting for obtaining CE marking
Support in the compilation and evaluation of the technical documents for submission
Support for the preparation and presentation of the registration dossier.
Support in the audit of the Notified Body.
PHARMACEUTICAL CONSULTING FOR MEDICAL AFFAIRS
Medical writing.
Scientific writing.
Scientific meeting consulting.
Medical education in Good Clinical Practice and training of research centers.
CLINICAL CENTER AUDIT
Center Audit.
Creation of final audit report.
WAREHOUSING AND DISTRIBUTION
Import, storage and distribution of medicines and medical devices in Europe.
Own warehouse located at our headquarters (León).
PHARMACOVIGILANCE FOR AUTHORIZED MEDICINAL PRODUCTS (AMP), MEDICINAL PRODUCTS UNDER DEVELOPMENT (DMP) AND MEDICAL DEVICES (MD)
QPPV (Qualified Person responsible for Pharmacovigilance) at European level - Local QPPV (Local Pharmacovigilance Officer) in Spain, Italy and Portugal.
Responsible for Eudravigilance for clinical trials.
Creation and maintenance of the Safety Management Plan.
Collection, management and evaluation of Serious Adverse Events (SAEs)
Preparation and writing of safety case narratives.
MedDRA coding.
Medical review and assessment of safety information.
Preparation of CIOMS forms and reporting of RAGIs.
Notification of safety information to developers.
Strategy creation and development of local literature searches.
Notification through Eudravigilance of individual safety case reports.
Preparation and submission of periodic reports (IPS, DSUR and annual safety reports).