CLINICAL RESEARCH SUPPORT SERVICE
CLINICAL RESEARCH SUPPORT SERVICE (CLINICAL STUDIES AND TRIALS)
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.
In addition, a support service is offered to emerging groups and affiliated clinical centers to help them get started on their first studies and commercial trials.
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.
PHARMACOVIGILANCE
- Implementation Plan for Pharmacovigilance Activities.
- Recording and evaluation of adverse events.
- Reporting of Serious and Unexpected Adverse Reactions (SEARs).
- Preparation and submission of periodic security reports.
- Notifications of the start and end of a study.
- Preparation and submission of annual and final reports.
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.
NURSING
- Administration and management of medication in research, including preparation, storage, inventory control, and traceability.
- Clinical monitoring of the patient, assessment of health status, follow-up on the patient’s progress, and detection/reporting of adverse events (including SAEs).
- Education and training for patients and Team regarding the trial, treatment, and study protocol.
- Coordination and management of studio visits, schedules, and adherence to timeframes.
- Logistical management of biological samples and coordination with relevant departments (hospital pharmacy, laboratory, etc.).
- Ensuring compliance with the protocol, Good Clinical Practices (GCP), and current regulations.
RESERVATIONS
If you have any trouble downloading the file mentioned above, you can access it via the following link.
CONTACT PERSONS
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Clinical Trials Coordinator: Herminia Amores Arrocha (herminia.amores@inibica.eu)
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Phone: (+34) 639 390 856
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Nursing Technician: Noelia Rodríguez Blázquez (noelia.rodriguez@inibica.es)