INDEPENDENT TESTS AND STUDIES
INiBICA CLINICAL RESEARCH SERVICES FOR INDEPENDENT CLINICAL TRIALS AND STUDIES
At INiBICA, we handle all the start-up procedures (from pre-start-up phases such as methodological analysis and feasibility studies) to presentation to the relevant authorities, coordination, study follow-up (start-up visits and monitoring), and closure of independent clinical trials, observational studies, and clinical research with medical devices.
We detail below:
METHODOLOGICAL SUPPORT
- Initial design and feasibility assessment of all types of clinical studies.
- Drafting, reviewing, or adapting the protocol and supplementary documents.
- Review of Scientific Reports public funding calls for which the project may be eligible.
CENTRAL COORDINATION / REGULATION
- Selection of centers and researchers.
- Processing of applications, clarifications, amendments, and notifications to the Spanish Agency for Medicines and Health Products (AEMPS) and Research Ethics Committees for Medicines (CEIm).
- Insurance policy management.
- Management of contracts with participating centers.
- Management of the supply of investigational medicinal products (IMP).
- Registration and periodic maintenance in national and international databases. Support in data dissemination.
- Preparation and maintenance of the studio's master and local files.
MONITORING
- Preparation of the specific risk-based monitoring plan.
- Preparation, implementation, and reporting of the various visits to the center: initiation, monitoring, and closure, both to Team principal Team and to the Pharmacy Department (accounting and reconciliation of investigational medication).
- Remote data monitoring.
- Control and management of biological samples and complementary tests.
- Resolution of queries and discrepancies.
- Database closure.
- Measures to encourage recruitment: regular newsletters and teleconferences.
DATA MANAGEMENT
- Calculation of sample size and statistical power.
- Randomization.
- Design and management of the electronic CRD.
- Performing statistical analysis and preparing reports necessary to draw conclusions.