• Two hospitalization rooms (4 beds and 8 recliners)
• Medical consultation with the necessary equipment.
• Work office and confidential documentation file.
• Laboratory with refrigerated centrifuge, freezers of -20º and -80º, autoclave, etc.
• Multipurpose room

• 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

Visit the Clinical Trials Unit (healthy volunteers and patients)

Visit the Unit and observe nursing procedures (blood collection, ECG, etc.) and the associated laboratory technician (sample management).

• Essay coordination and organization
• Test preparation
• Trial Closure
• UCA-EC use (lingerie, light, heating, maintenance of devices)
• Unit Income
• Sending samples to the central laboratory
• Sending ECG to the central laboratory
• Study medication management

* Rates subject to 21% withholding

Sanitary Fungible

• Extraction (unit)
• ECG + Constants (unit)

Advice on the design and methodology of the clinical trial and EPAs

• Consultation and report preparation

Documentation clinical trial and EPAs

• Protocol writing support
• Protocol adaptation
• Translation of the protocol summary
• Deed of consent
• Consent Translation
• Promoter file preparation
• Pharmacy file preparation *
• Research File Preparation

Identification of participating clinical trial centers and EPAs

• Identification, visit and selection of study centers
• Evaluation and approval of the list of centers

Presentation to Regulatory Authorities and CEICs clinical trials and EPAs

• Presentation of an observational study to the AEMPS for classification
• Preparation documentation and submission request for authorization
• Tax payment
• Clarification Management
• EudraCT application and completion Annex 1 *
• Preparation of the researcher's manual *
• Advice to the researcher in response to clarifications

Project management and clinical trial monitoring and EPAs

• Development of the monitoring plan
• Monitor Training
• Global Project Management
• Home-center visits
• Home-pharmacy visits *
• Startup visits review
• Notice of initiation to AEMPS and CEIC
• File Maintenance
• Preparing and performing  researchers meeting
• Preparation, development and reporting of periodic monitoring visits
• Preparation, visits for sample management and pharmacy reports *
• Annual report writing
• Sending of annual report to CEICs, AEMPS, etc.
• Preparation documentation amendment to the protocol
• Send request amendment / notification to AEMPS and CEIC
• Closing Visits
• Closing visits to pharmacy *
• Support for the resolution of queries and database closure
• Center closure communication to CEIC and AEMPS
• Preparation of the final report

Medication, samples and complementary tests of the clinical trial

• Stock medication control
• Distribution of medication to the centers
• Control and management of biological samples
• Control and management of complementary tests

Pharmacovigilance of the clinical trial and EPAs

• Pharmacovigilance advice
• Pharmacovigilance activities implementation plan
• Update of the available documentation on the reference safety information of the medications during the study
• Periodic reconciliation of serious adverse events (AAGs) under the pharmacovigilance procedure
• Drafting of the annual safety report
• Drafting of the annual safety report format DSUR *
• Management of AAGs, Serious Adverse Reactions (RAGs) and / or SUSARs
• Processing / sending safety reports AEMPS / CEIC / CCAA
• Final security report writing

* Only applicable in the case of clinical trials