INiBICA's clinical research services for independent clinical trials and studies
At INiBICA, we carry out all the start-up procedures (from pre-initiation phases such as methodological analysis and feasibility studies), submission to the relevant authorities, coordination, study follow-up (kick-off visits and follow-up visits) and closure of independent clinical trials, observational studies and clinical investigation of medical devices.
Details are shown below:
Methodological support
- Initial design and feasibility assessment of all types of clinical studies.
- Writing, reviewing or adapting the protocol and complementary documents.
- Review of scientific reports for public funding calls for which the project is eligible.
Central coordination / Regulation
- Selection of centres and researchers.
- Processing of applications, clarifications, amendments and notifications to the Spanish Agency for Medicines and Healthcare Products (AEMPS) and Ethics Committees for Research with medicinal products (CEIm).
- Management of insurance policies.
- Management of contracts with participating centres.
- Management of investigational medicinal product (IMP) supply.
- Registration and periodic maintenance in national and international databases. Support in data dissemination.
- Development and maintenance of master files and study premises.
Monitoring
- Preparation of the specific risk-based monitoring plan.
- Preparation, development and reporting of the different visits to the centre: initiation, monitoring, closure for both the principal investigator’s team and the Pharmacy Service (accounting and reconciliation of investigational medicinal products).
- Remote data monitoring.
- Control and management of biological samples and complementary tests.
- Resolution of queries and discrepancies.
- Database closing.
- Measures to encourage recruitment: regular newsletters and teleconferences.
Pharmacovigilance
- Implementation plan for Pharmacovigilance activities.
- Recording and assessment of adverse events.
- Reporting of serious or unexpected adverse reactions.
- Provision and submission of regular security reports.
- Notifications of start and end of study.
- Provision and submission of annual reports and the final report.
Data management
- Calculation of sample size and statistical power.
- Randomization.
- Design and management of the electronic case report form (eCRF).
- Conducting statistical analysis and reports necessary to obtain conclusions.
