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
- 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)@iislafe.es