Actualización de las cuotas de gestión de la investigación clínica

 

La Junta de Gobierno de FISABIO ha aprobado las nuevas cuotas de gestión para la investigación clínica que se desarrolle en los centros del ámbito de FISABIO y que serán de aplicación a partir del día 1 de enero de 2017.

Las cuotas* por la gestión de nuevos estudios clínicos son:

- Cuota única de gestión del expediente (sólo para Ensayos Clínicos):                        
                                 1-3- centros:    1.000 €
                                 4-7- centros:    1.500 €
                                 ≥ 8 centros:      2.000 €  

- Gestión del contrato (para todos los estudios): 500 €

- Gestión de adenda al contrato (para todos los estudios): 300 €

* estos precios no incluyen el IVA correspondiente.
 

Gestión del expediente del ensayo clínico (se cobrará a la recepción del expediente en FISABIO):

 

  • Actuación como ventanilla única: FISABIO recaba toda la información necesaria para trasladarla al personal designado en cada Departamento de Salud con la finalidad de obtener las autorizaciones internas pertinentes y agilizar los trámites en la firma de los contratos por parte de los directores gerentes e investigador principal.
  • Recogida del documento de idoneidad de las instalaciones para facilitárselo al promotor.
  • Registro, seguimiento y cierre del ensayo clínico en la base de datos de FISABIO y actividad informativa a los centros implicados de su ámbito de actuación.
Gestión del contrato y de las adendas a los contratos (se cobrará a la firma del contrato/adenda):
  • Revisión y negociación del borrador del contrato por parte del área de estrategias en investigación y EECC de FISABIO.
  • Recabo de las firmas correspondientes.

Contacto: ensayos_fisabio@gva.es


 

Clinical Management Unit
     
 
   

 

 
 

The Clinical Management Unit of FISABIO is set up to encourage and strengthen the development of clinical studies promoted by external companies in order to support and guide the researchers who wish to establish a clinical trial or post-authorisation study of their own initiative.

Among the objectives of the management unit of the research contracted by FISABIO is the continuous improvement of the management indicators referring to the time from when the proposal has been received until the clinical trial commences; the establishment of recruitment (recruitment rate, trials without recruitment and speed of recruitment); and the guarantee of the quality of information acquired in the study.

RESEARCH CONTRACT WITH EXTERNAL DEVELOPERS

  • To establish and maintain contact with the developers, researchers, Management Centre where they carry out the trials, CROs, health authority and CEICs. 
  • Preparation, negotiation and administrative management of the established contracts with the developer companies according to the current legislation on the subject of clinical trials.
  • Viability studies and the selection of doctors for the development of new proposals.  


CLINICAL RESEARCH OF AN OWN INITIATIVE

Questions posed:

-       Has a drug been administered to a group of patients in conditions other than those authorised?
-       Has a drug been given to a healthy subject with the aim to evaluate kinetics, activity of a biological indicador, effectiveness or safety?    
-       Is it the first time that the drug has been administered to a subject?
-       Is there randomisation in place for assigning subjects to different study groups?
-      Are the patients selected exposed to a particular drug in agreement with the authorised conditions?

If you have answered “YES” to any of the previous questions, then your study classifies as a Clinical Study or Post-Authorisation Study and should comply with the specific legislation in force. 

-      Methodological support for the design of the clinical research studies of its own initiative: methodology of clinical trials, calculate the simple size, drafting of protocol and the development of notebooks of data collected.
-      Guidance about all the legal processes in order to be able to establish a clinical study of its own initiative: processing through the AEMPS, insurance policies, and approvals of the CEICS.   
-      Support in the search for funding as a result of the cost derived from commissioning a study of its own initiative.  
 

Rate for the compensation of services of the Clinical Management Unit


If you are an external developer or researcher of FISABIO and you need the support offered by the Clinical Management Unit then contact by email to ensayos_fisabio@gva.es or by phone to + 00 34 96 192 59 63.