Clinical Research

Clinical Research Management

The Clinical Research Management Area's mission is to provide support and advice to our site investigators on ethical, methodological, regulatory and management issues for the conduct and development of their clinical studies by providing specialization, experience and know-how, and ensuring that they are performed according to the ethical and methodological standards and complying with the applicable regulations.

It provides a wide portfolio of services adapted to each study’s needs and throughout all the different phases, from the initial design to its implementation and conduction.

  • Clinical studies design
  • Writing, revision or adaptation of study protocols and complementary documents
  • Revision of grant applications or reports
  • Evaluation of feasibility of clinical studies
  • Selection of study Sites / investigators
  • Submission of applications, clarifications, amendments, and notifications to the Spanish Agency for Medicines and Health Products (AEMPS) and Committees on Ethics of Research with Medicines (CEIm)
  • Insurance management
  • Contract management
  • Investigational drug management
  • Study registration and periodic maintenance on national and international registry websites
  • Preparation and maintenance of the files and master files of the study
  • Writing of Risk-based monitoring plans
  • Conducting and reporting of the different visits to the site: initiation, routine, close-out
  • Remote data monitoring
  • Management of biological samples and complementary tests
  • Data queries resolution and database lock
  • Close-out visits on Pharmacy (research medication accountability and reconciliation)
  • Measures to improve recruitment: periodic newsletters and teleconferences
  • Planning of implementation activities for Pharmacovigilance
  • Registration and evaluation of adverse events
  • Notification of suspected unexpected serious adverse reactions (SUSAR)
  • Writing and submission of periodic safety reports
  • Initiation and end of the study communication
  • Writing and submission of annual and final reports

In collaboration with the Unit of Technological Innovation and Bioinformatics:

  • Sample size and statistical power calculation
  • Randomization
  • Electronic CRF design and management
  • Database creation and validation
  • Statistical analysis and writing of statistical reports
Logotipos de Scren, Ecrin y RedFGI

The Clinical Research Management Unit is a member of the Spanish Clinical Research Network (SCReN) of the National Institute of Health Carlos III.

Team Members

Antonio Miguel Luque Pineda
Antonio Miguel Luque Pineda
José Carlos Garrido Gracia
José Carlos Garrido Gracia

Location

Edificio IMIBIC
Planta 0
Avenida Menéndez Pidal s/n 14004
Córdoba (España)