INDEPENDENT RESEARCH AND STUDIES
INiBICA CLINICAL RESEARCH SERVICES FOR INDEPENDENT CLINICAL TRIALS AND STUDIES
At INiBICA, we handle all aspects of the start-up process (from pre-initiation phases such as methodological analysis and feasibility studies) through submission to the relevant authorities, coordination, study monitoring (initiation and monitoring visits), and the completion of independent clinical trials, observational studies, and clinical research involving medical devices.
The details are as follows:
METHODOLOGICAL SUPPORT
- Initial design and feasibility assessment of all types of clinical studies.
- Drafting, reviewing, or adapting the protocol and supporting documents.
- Scientific Reports 's review of public funding calls for which the project may be eligible.
CENTRAL COORDINATION / REGULATION
- Selection of institutions and researchers.
- Processing of applications, clarifications, amendments, and notifications to the Spanish Agency for Medicines and Health Products (AEMPS) and the Ethics Committees for Research Involving Medicines (CEIm).
- Insurance Policy Management.
- Contract management with participating centers.
- Management of the Supply of Investigational Medicinal Products (IMP).
- Registration and periodic maintenance in national and international databases. Support for data dissemination.
- Creation and maintenance of the firm's master and local files.
MONITORING
- Preparation of a specific, risk-based monitoring plan.
- Preparation, implementation, and reporting on the various site visits: initiation, monitoring, and closure, both to the principal investigator’s Team and to the Pharmacy Department (accounting and reconciliation of study medications).
- Remote data monitoring.
- Control and management of biological samples and ancillary tests.
- Resolving Queries and Discrepancies.
- Closing the database.
- Measures to encourage recruitment: regular newsletters and conference calls.
DATA MANAGEMENT
- Calculating Sample Size and Statistical Power.
- Randomization.
- Design and management of the electronic CRD.
- Conducting the statistical analysis and preparing the necessary reports to draw conclusions.