Andalusian Public Health System Virtual Library
RESEARCH+
INiBICA Clinical Research Services to independent clinical trials and studies

From INiBICA we carry out all the start-up procedures (from pre-initiation phases such as methodological analysis and feasibility studies), presentation to relevant authorities, coordination, study follow-up (initiation and monitoring visits) and closure of independent clinical trials, observational studies and clinical research with medical devices.

Details are as follows:

Methodological support
  • 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 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 Drug Research Ethics Committees (CEIm).
  • Management of insurance policies.
  • Contract management with participating centers.
  • Investigational medicinal product supply management (IMP).
  • Registration and periodic maintenance in national and international databases. Support in data disclosure.
  • Preparation and maintenance of the study's master and local files.
Monitoring
  • Preparation of the specific risk-based monitoring plan.
  • Preparation, development and report of the different visits to the center: initiation, monitoring, closure both to the principal investigator's Team and to the Pharmacy Service (accounting and reconciliation of research medication).
  • Remote monitoring of data.
  • Control and management of biological samples and complementary tests.
  • Resolution of queries and discrepancies.
  • Closing of database.
  • Measures to encourage recruitment: periodic newsletters and teleconferences.
Pharmacovigilance
  • Implementation plan for pharmacovigilance activities.
  • Recording and evaluation of adverse events.
  • Notification of Serious and Unexpected Adverse Reactions (SUSARs).
  • Preparation and submission of periodic security reports.
  • Start and end of study notifications.
  • Preparation and submission of annual and final reports.
Data Management
  • Sample size calculation and statistical power.
  • Randomization.
  • Design and management of the electronic CRD.
  • Performing the statistical analysis and reporting necessary to draw conclusions.