SERVICIO DE APOYO A LA INVESTIGACIÓN CLÍNICA
SERVICIO DE APOYO A LA INVESTIGACIÓN CLÍNICA (ESTUDIOS Y ENSAYOS CLÍNICOS)
At INiBICA, we handle all the start-up procedures (from pre-start-up phases such as methodological analysis and feasibility studies) to presentation to the relevant authorities, coordination, study follow-up (start-up visits and monitoring), and closure of independent clinical trials, observational studies, and clinical research with medical devices.
Además, se ofrece un servicio de apoyo a grupos emergentes y clínicos asociados para iniciarse en la realización de sus primeros estudios y ensayos comerciales.
We detail below:
METHODOLOGICAL SUPPORT
- Initial design and feasibility assessment of all types of clinical studies.
- Drafting, reviewing, or adapting the protocol and supplementary documents.
- Review of Scientific Reports public funding calls for which the project may be eligible.
CENTRAL COORDINATION / REGULATION
- Selection of centers and researchers.
- Processing of applications, clarifications, amendments, and notifications to the Spanish Agency for Medicines and Health Products (AEMPS) and Research Ethics Committees for Medicines (CEIm).
- Insurance policy management.
- Management of contracts with participating centers.
- Management of the supply of investigational medicinal products (IMP).
- Registration and periodic maintenance in national and international databases. Support in data dissemination.
- Preparation and maintenance of the studio's master and local files.
MONITORING
- Preparation of the specific risk-based monitoring plan.
- Preparation, implementation, and reporting of the various visits to the center: initiation, monitoring, and closure, both to Team principal Team and to the Pharmacy Department (accounting and reconciliation of investigational medication).
- Remote data monitoring.
- Control and management of biological samples and complementary tests.
- Resolution of queries and discrepancies.
- Database closure.
- Measures to encourage recruitment: regular newsletters and teleconferences.
PHARMACOVIGILANCE
- Plan for implementing pharmacovigilance activities.
- Recording and evaluation of adverse events.
- Notification of Serious and Unexpected Adverse Reactions (SUARs).
- Preparation and submission of periodic safety reports.
- Notifications of the start and end of the study.
- Preparation and submission of annual and final reports.
DATA MANAGEMENT
- Calculation of sample size and statistical power.
- Randomization.
- Design and management of the electronic CRD.
- Performing statistical analysis and preparing reports necessary to draw conclusions.
ENFERMERÍA
- Administración y manejo de medicación en investigación, incluyendo preparación, conservación, control de stock y trazabilidad.
- Monitorización clínica del paciente, valoración del estado de salud, seguimiento evolutivo y detección/notificación de eventos adversos (incluidos SAEs).
- Educación y formación a pacientes y equipo sobre el ensayo, tratamiento y protocolo del estudio.
- Coordinación y gestión de visitas del estudio, agendas y cumplimiento de ventanas temporales.
- Gestión logística de muestras biológicas y coordinación con servicios implicados (farmacia hospitalaria, laboratorio, etc.).
- Garantía del cumplimiento del protocolo, Buenas Prácticas Clínicas (GCP) y normativa vigente.
RESERVATIONS
If you have any problems downloading the above file, you can access it via the following link link.
CONTACT PERSONS
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Clinical Trials Coordinator: Herminia Amores Arrocha (herminia.amores@inibica.eu)
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Phone: (+34) 639 390 856
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Técnica de Enfermería: Noelia Rodríguez Blázquez (noelia.rodriguez@inibica.es)