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.
RATES

The rates for the support service for clinical trials and independent studies can be found in the following document: ↪ RATES.