Clinical trials, observational studies and clinical trials with medical devices

Clinical trials, observational studies and clinical trials with medical devices
INiBICA carries out all tasks related to contract management, monitoring and invoicing of clinical trials, observational studies and clinical trials with medical devices.

INiBICA also acts as a liaison with the provincial Ethics Committee, as well as with public centres.

1. Management of clinical studies where FCádiz acts as a sponsor

Independent Clinical Research Support Service, aimed at researchers who require methodological support, statistical analysis and advice for conducting clinical studies.

2. Contract management.

- Advice on clinical trials, observational studies and clinical trials with commercial medical devices, both to researchers and companies (sponsors, CRO...)

- Management of economic contracts. The Andalusian Public Health System has one single model contract for conducting clinical studies, which regulates the legal and economic aspects of all the stakeholders.

- Other administrative procedures related to the signing of contracts:

      • Documents required by regulatory authorities (Suitability of facilities, where applicable)
      • Exemption from administrative contract management (where applicable)
      • Local documents (provincial Ethics Committee)

- Support to the provincial Ethics Committee and Centres in the management of documents in relation to clinical trials:

      • Favourable view
      • Compliance of the Centre

- Documents in electronic format:

      • The model contract in Word format, which contains the legal clauses and provisions.
      • The Economic Report (ER) template, in Excel format, which contains the budget available for the study.
      • Annex 2 to the contract, in Excel format, which specifies the breakdown by visits, additional payments and extraordinary direct costs, as well as invoicing data (if applicable).
      • Annex 3: Sponsor's authorization to publish status information and other basic clinical research data.
      • Annex 4: Additional agreements to the model contract.
      • Annex 5: Supply of medication/medical device.

- Signature circuit according to each Centre.

- Management of the opening, execution and closing of the study.

3. Invoicing.

- Issuance of first administrative management invoice, after signing the contract.

- Economic follow-up and invoicing of clinical studies.

- Management procedures as per economic items of R+D+i Promotion and Research Team.

4. Structure of the clinical trial management area

Responsible for the clinical trial area (Pending incorporation)

Clinical trial management technician: Irene Andría Retes

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