Support services for trials and clinical studies promoted by the industry

At INiBICA we carry out the contractual management, monitoring and billing of Clinical Trials, Observational Studies and Clinical Research with Medical Devices.

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

1. Contract management
  • Advice on Clinical Trials, Observational Studies and Clinical Research with commercial health products, both for researchers and companies (promoters, CROs…).
  • Management of economic contracts. The Andalusian Public Health System has a single contract model for conducting clinical studies, which regulates the legal and economic aspects of the parties.
  • Other administrative procedures linked to the signing of contracts:
    • Documents required by the regulatory authorities (Suitability of Facilities, in those cases where appropriate).
    • Exemption from administrative management of contracts, in the cases in which it proceeds.
    • Local documents (Provincial Ethics Committee).
  • Support to the Provincial Committee and Centers in the management of documentation in relation to Clinical Studies:
    • Favorable opinion.
    • Center Compliance.
  • Documents in electronic format:
  • Circuit of signatures according to each Center.
  • Management of the start-up of the study, opening, execution and closure of the study.
2. Billing
  • Issuance of the first administrative management invoice, after signing the contract.
  • Economic follow-up and invoicing of clinical studies.
  • Management procedures in application of the economic items for the Promotion of R+D+i and the Research Team.
3. Structure of the Clinical Trials Management Area

– Head of Clinical Trials Area: Mónica Saldaña.

– Coordinator of Clinical Studies: Laura Quintana.

– Clinical Studies Management Technician: Irene Andría Retes.

– Contact: /