Clinical Research

Clinical Research Services

Specialised in the implementation of clinical studies, we offer this service for researchers at IIS La Fe, CROs and promoters in the different stages of a clinical study.

To request this service, please contact: investigacion_clinica(ELIMINAR)

1. Early stage

  • Methodological support: Design (justification, hypothesis, inclusion and exclusion criteria, sample size calculation, preparation of the randomization scheme, statistical analysis, results interpretation and presentation).
  • Documentation Drafting and Revision (Protocol, Participant Information Sheets and Consent Forms, Data Collection Logbook (DCL), etc.)
  • Budget planning.
  • Advisory and consulting service in selecting the research centers and staff. Clinical Trials Feasibility.
  • Advice on ethical and legal requirements and study documentation.

2. Implementation stage

  • Submission to regulatory agencies (CEIm, AEMPS and CCAA).
  • Providing response and clarification (in case of CEIm) and response and correction (in case of AEMPS).
  • Registration at and regular maintenance thereof.
  • Contracts management and financial reports revision.
  • Insurance procurement.
  • Monitoring plan preparation.
  • Sponsor file preparation.
  • Researcher file preparation.

3. Study development

  • Project management (cordination).
  • Trial management (health material, drugs and biological samples).
  • Setting up the trial site and staff training.
  • Initial inspection report.
  • Notification on setting up the site to AEMPS y CEIm.
  • Monitoring and monitoring visits reports preparation.
  • Distance monitoring,
  • Advisory and consulting service in GCP.
  • Nursing procedures: vital signs monitoring and recording, EKG, other procedures depending on the trial, collection, processing, storing and shipping of biological samples.
  • Document amendments preparation (protocol, site enlargement ...) and expedition to CEIm y AEMPS.
  • Expedition of AE, SAE and SUSAR reports.
  • Annual reports preparation and expedition to CEIm y AEMPS

4. Completion

  • Final trial clouse-out site visit and report.
  • Statistical analysis.
  • Final report preparation.
  • Trial documentation storing


Researchers at IIS Hospital La Fe can request support services from Study Coordinator for the development of clinical trials.

For further information, please contact: investigacion_clinica(ELIMINAR)