Director:   Dr. Jesús Cebrecos
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The Phase 1 Clinical Trials Unit was established in 1996.We are a full service provider (clarity, skill, and commitment) in phase I clinical research.
The conduct of the trial (subject’s screening & recruitment, experimental phase, and follow-up) are carried out at Hospital Dos de Maig (Barcelona).
The unit carries out its activity, following the Good Clinical Practices principles (GCP), according to applicable laws and guidelines.

WORKING AREAS

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-Study Design and Protocol writing/review
-CRF (Case Record Form) design and development
-Authorization request :EUDRACT, EC, MS competent authority  (AEMPS)
-Own Database (registered at the “Agencia de Protección de  Datos” as required by personal data protection law)
-Volunteer Screening and Recruitment
-Experimental Phase
-Bioanalysis/ Pharmacokinetics
-Data management and statistics
-Clinical Report Medical writing
-Storage and Archival of Study files
-Scientific Advice / Expert’s Report

SERVICES AND FACILITIES

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-32 beds and leisure/break area
-Hospital Dos de Maig EC
-ICU adjacent to Phase 1 Unit
-In-house pharmacy
-Project Management (from protocol design to Clinical Report)
-Specialized Medical Team
-Specialized nursing
-All watches in the Unit synchronized, Digital ECGs (that support  FDA defined XML standard format), pulse oximetry, centrifuge,  freezer –80ºC, dry ice
-SOPs (Standard Operational Procedures)
-Quality Assurance (Clinical Trial audits according to ICH, GCP,  GLP, and ISO 9001:2000)
-Calibration and Instrument control
-Functional Integration with laboratory (central and intra hospital)  Units:

          -Sample management
          -Bioanalysis/ Pharmacokinetic
          -Pharmacogenetics
          -Immunology
          -Biochemistry
          -Hematology
          -Toxicology
          -R&D
          -QAU

ASSESMENT

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-First-into-man
-Bioavailability
-Bioequivalence
-Pharmacokinetic (PK)
-Pharmacodynamic (PD)
-Safety
-Tolerability to increase dosage
-Dose-Response

STUDIES

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-Single dose
-Multiple dose
-Modified Release formulations
-Drug Interaction studies
-Food effect studies
-QTc measurement

DATA MANAGEMENT AND STATISTCS ANALYSES

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-Data Entry and Data Management
-Statistical Analysis Plan (SAP)
-Data Blind Review and Quality Control
-Safety analyses and statistical Report (MedDRA, WHO  dictionaries, and SAS software)
-PD/PK analyses and statistical Report (SAS and WinNolin  Software)