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:

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 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.
Monitoring
  • 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
  • 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.
Data management
  • Calculation of sample size and statistical power.
  • Randomization.
  • Design and management of the electronic database.
  • Carrying out the statistical analysis and reports necessary to obtain conclusions.