INiBICA’s clinical research services for independent clinical trials and studies

INiBICA's clinical research services for independent clinical trials and studies

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

Details are shown below:

Methodological support
  • Initial design and feasibility assessment of all types of clinical studies.
  • Writing, reviewing or adapting the protocol and complementary documents.
  • Review of scientific reports for public funding calls for which the project is eligible.
Central coordination / Regulation
  • Selection of centres and researchers.
  • Processing of applications, clarifications, amendments and notifications to the Spanish Agency for Medicines and Healthcare Products (AEMPS) and Ethics Committees for Research with medicinal products (CEIm).
  • Management of insurance policies.
  • Management of contracts with participating centres.
  • Management of investigational medicinal product (IMP) supply.
  • Registration and periodic maintenance in national and international databases. Support in data dissemination.
  • Development and maintenance of master files and study premises.
  • Preparation of the specific risk-based monitoring plan.
  • Preparation, development and reporting of the different visits to the centre: initiation, monitoring, closure for both the principal investigator’s team and the Pharmacy Service (accounting and reconciliation of investigational medicinal products).
  • Remote data monitoring.
  • Control and management of biological samples and complementary tests.
  • Resolution of queries and discrepancies.
  • Database closing.
  • Measures to encourage recruitment: regular newsletters and teleconferences.
  • Implementation plan for Pharmacovigilance activities.
  • Recording and assessment of adverse events.
  • Reporting of serious or unexpected adverse reactions.
  • Provision and submission of regular security reports.
  • Notifications of start and end of study.
  • Provision and submission of annual reports and the final report.
Data management
  • Calculation of sample size and statistical power.
  • Randomization.
  • Design and management of the electronic case report form (eCRF).
  • Conducting statistical analysis and reports necessary to obtain conclusions.