Research

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)@iislafe.es

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 www.clinicaltrials.gov 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

More

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)@iislafe.es