INiBICA clinical research services to independent clinical trials and studies
From INiBICA we carry out all the start-up procedures (from pre-start phases such as methodological analysis and feasibility studies) presentation to relevant authorities, coordination, follow-up of the study (start-up visits and monitoring) and closure of independent clinical trials , Observational Studies and Clinical Research with Health Products.
We detail below:
- Initial design and feasibility assessment of all types of clinical studies.
- Drafting, revision or adaptation of the protocol and complementary documents.
- Review of scientific reports for the public funding calls to which the project may apply.
Central coordination / Regulation
- Selection of centers and researchers.
- Processing of requests, clarifications, amendments and notifications to the Spanish Agency for Medicines and Health Products (AEMPS) and Ethics Committees for Research with Medicines (CEIm).
- Management of insurance policies.
- Management of contracts with participating centers.
- Management of the supply of the investigational drug (IMP).
- Registration and periodic maintenance in national and international databases. Support in data disclosure.
- Preparation and maintenance of master and local files of the study.
- Preparation of the specific monitoring plan based on risk.
- Preparation, development and report of the different visits to the center: start, monitoring, closure both to the principal investigator’s team and to the Pharmacy Department (accounting and reconciliation of the investigational medication).
- Remote data monitoring.
- Control and management of biological samples and complementary tests.
- Resolution of queries and discrepancies.
- Database shutdown.
- Measures to encourage recruitment: regular newsletters and teleconferences.
- Pharmacovigilance activities implementation plan.
- Registration and evaluation of adverse events.
- Notification of Serious and Unexpected Adverse Reactions (RAGIs).
- Preparation and sending of periodic security reports.
- Start and end of study notifications.
- Preparation and submission of annual and final reports.
- Calculation of sample size and statistical power.
- Design and management of the electronic database.
- Carrying out the statistical analysis and reports necessary to obtain conclusions.