• Early phase clinical trials unit.

  Treatment and monitoring room: administration of medications and monitoring of participants in the clinical trial (7 chairs and 1 bed)
  Medical consultation with necessary equipment for a complete examination.
  Administrative and archiving area for confidential documentation.
  Laboratory for processing and archiving of biological samples with refrigerated centrifuge, -20º and -80º freezers
  Measures to guarantee the safety of patients and the proper development of the study.

• Clinical Research and Clinical Trials Unit.

  Office on 7 Right with 5 jobs
  Office on the -2 Right. With 2 workstations.

• Phase I Clinical Trials Unit certified by the Regional Ministry of Health of the Community of Madrid
• Belongs to ECRIN (European Clinical Research Infrastructure Network)

**Consult prices with the unit

Early Phase EC Unit (UEC-FT)

Document management. Management and quality control
Organization of the trial: Participation in pre-start, beginning and closing visits of the studies. Preparation of activity documents. Appointment of patients. Organization of medical and nursing staff to provide 24-hour coverage, 365 days a year
Nursing procedures (administration of treatments, blood draws, clinical tests, etc.)
Laboratory procedures (handling and shipping of samples, management and custody of laboratory kits, etc.).

Advice on design and methodology of clinical trials and Observational Studies with Medications (EOMs)

Consultation and preparation of report
Preparation of clinical trial documentation and observational studies (protocol, consents, Investigator Manual, IMPD)
Selection of centers

Study management and monitoring tasks

Presentation to regulatory authorities (AEMPS and CEIm), management of clarifications, etc.
Preparation of the file of the promoter, the researcher and the Pharmacy
Preparation of the monitoring plan and training of monitors
Global management
Initial, monitoring and closing visits (research team and Pharmacy. Preparation of reports
Preparation of documentation for amendments to the protocol
Annual reports
Support in query resolution and database closure
Center closure communication
Preparation of final report
Medication, samples and complementary clinical trial tests

Medication stock control
Control and management of biological samples
Control and management of complementary tests
Distribution of medication to centers
Pharmacovigilance of clinical trials and observational studies

Advice on pharmacovigilance and implementation plan for related activities
Update of available documentation on baseline safety information of medications during the development of the study
Periodic reconciliation of serious adverse events (SAEs) under pharmacovigilance procedure.
Drafting of the annual security report (also drafting in DSUR format)
Management of SAEs, Serious Adverse Reactions (SARs) and/or SUSARs
Processing/sending security reports and the final report to the competent authorities