Andalusian Public Health System Virtual Library
RESEARCH+
Support services for industry-sponsored clinical trials and studies

From INiBICA we carry out the contractual management, follow-up and invoicing of Clinical Trials, Observational Studies and Clinical Research with Medical Devices.

We are also liaison with the provincial Ethics Committee and Public Centers.

Contract management
  • Advice on Clinical Trials, Observational Studies and Clinical Research with commercial medical devices, both to researchers and companies (developers, CRO...).
  • Management of financial contracts. The Andalusian Public Health System has a single model contract for the performance of clinical studies, which regulates the legal and economic aspects of the parties.
  • Other administrative procedures related to the signing of contracts:
    • Documents required by the regulatory authorities (Suitability Facilities, in those cases where applicable).
    • Exemption from administrative management of contracts, in appropriate cases.
    • Local documents (Provincial Ethics Committee).
  • Support to the Provincial Committee and Centers in the management of Documentation in relation to Clinical Studies:
    • Favorable opinion.
    • Conformity of the Center.
  • Documents in electronic format:
  • Signature circuit according to each Center.
  • Management of study start-up, opening, execution and closure of the study.
Billing
  • Issuance of the first invoice for administrative management, after signing the contract.
  • Economic follow-up and billing of clinical studies.
  • Management procedures in application of the economic items of R&D&I Promotion and Team Researcher.
3. Structure of the Clinical Trials Management Area

- Clinical Trials Area Manager: Mónica Saldaña.

- Clinical Studies Coordinator: Laura Quintana.

- Clinical Trials Management Technician: Irene Andría Retes.

- Contact: irene.andria@juntadeandalucia.es / irene.andria@inibica.es