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
- 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 firstname.lastname@example.org or by phone to + 00 34 96 192 59 63.