COMMERCIAL TESTS AND STUDIES
SUPPORT SERVICES FOR CLINICAL RESEARCH PROMOTED BY THE PHARMACEUTICAL INDUSTRY
At INiBICA, we handle the contractual management, monitoring, and billing of clinical trials, observational studies, and clinical research with medical devices.
We also liaise with the provincial Ethics Committee and public centers.
Links of interest
1. Contract management
➡️ Management of financial contracts. The Andalusian Public Health System has a single contract model for conducting clinical studies, which regulates the legal and financial aspects of the parties involved.
➡️ Other administrative procedures related to contract signing:
- Documents required by regulatory authorities (suitability of facilities, where applicable).
- Exemption from administrative management of contracts, where applicable.
- Local documents (Provincial Ethics Committee).
- Clinical trials with drugs:
- Observational studies with drugs:
- Clinical research with medical devices:
- Equipment transfer:
- Others:
If you have any problems downloading the files mentioned above, you can access them via the following link.
2. Billing
- Issuance of invoices in accordance with the financial terms and conditions set forth in the commercial clinical research agreement.
- Advising research staff on the application of financial items.
The Administrative Management costs applicable in the 2026 annuity are as follows:
- Administrative Management – New contract: €1,382.25
- Administrative Management – Contract Addendum Financial Report: €544.34
- Administrative Management – Contract Addendum No. Financial Report: €345.72
- Master File Management: €654.37
These amounts will be updated annually in line with changes in the CPI.
3. Clinical Trial Management Area Structure
Mónica Saldaña.
– Head of Clinical Trial Management:
Irene Andría Retes.
irene.andria@inibica.eu