We offer services of clinical trial implementation; this applies to the Institute's researchers, CROs, sponsors and can be applied for in different stages of the clinical trial in question.
To apply for this service, contact us at: investigacion_clinica(ELIMINAR)@iislafe.es
Before the Clinical Phase of the Trial Commences
- 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.
- 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
During the Clinical Conduct of the Trial
- Project management (co-ordination)
- 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.
After Completion or Termination of the Trial
- Final trial clouse-out site visit and report.
- Statistical analysis.
- Final report preparation.
- Trial documentation storing
The Hospital's Statistical Analysis Platform gives support to the unit in question in sample size calculation, randomization scheme preparation, statistical analysis and results interpretation. Also, in collaboration with the Institute's IT area, the Electronic Data Collection Logbook is designed, created and maintained.
The Hospital's researchers can ask the Study Coordinator for support services in developing clinical trials.
For more information contact us at: investigación_clinica(ELIMINAR)@iislafe.es