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Functional Phase I Unit

Clinical research at ICO follows two main objectives:
• To contribute to improve cancer therapies.
• To offer to patients the best therapeutic alternatives in the setting of new strategies in cancer.

Clinical research in early phases is considered as a priority issue in ICO since it allows patients to access to alternative therapies at the same time that the institution contributes to the premature development of new treatments, an area which is currently in a great innovation moment.

ICO’s clinical research in early phases or first in human setting is performed in Functional Phase I Unit (UFF1). This unit implements their activities in ICO-L’Hospitalet without limiting that other ICO sites could carry out clinical trials in early phases. UFF1 is integrated into Research Area and it is under the direction of Ramon Salazar as a Director of Research and Margarita Garcia as a Head of Clinical Research, while Marta Gil is in charge of executive director and Carmen Cuadra serves as General Coordinator.

Mission

To develop the performance of early phase clinical trials based on robust scientific criteria and with a preclinical validated basics, with the vision of promoting and evaluate a guided medicine according to criteria that includes molecular specific variants and new therapies as immunotherapy or oncovirus.

Objectives

1. To develop premature clinical research in ICO, from the early design of phase I and II trials, their start-up, execution and result analysis.
2. To bring a health care of excellence to patients those contribute in this research projects.

Activities

  • Development, organization and management of clinical research in early phases.
  • Proved accreditation on the pre-clinic and clinic studies.
  • Premature application of new treatments.
  • Resource optimization for Patient’s treatments.
  • Knowledge generation in applying rationale and new treatment management.
  • Logistic support in clinical trials development with documented standard operating procedures of all procedures and accredited compliance of good clinical practices under current national and international regulations.
  • Pharmacokinetics studies (PK) and GLPs accredited compliance by GENCAT yearly renewed.
  • Pharmacodynamics studies: biomarkers and serial biopsies.
  • Hospitalization facilities available.
  • 24 hours of health care: structured through 24 hours ICO service with a trained medical team.
  • Intensive care and emergency attention if needed.

Human Team

Head of corporative Clinical Research: Margarita García Martín

UFF1 Director: Ramón Salazar Soler

Executive Director:  Marta Gil Martí

Medical Team: Dr. Maria Jové Casulleras, Dr Agostina Stradella, Dr. Mariona Calvo Campos, Dr Juan Jesús Martín Liberal.

General Coordinator:  Carmen Cuadra Amor

Financial and administrative Management:  Cristina Feliu Sanchez

 Administrative Manager: Ana Horno Navarro

Clinical trial Technicians (Trial coordinators): Marina Figuerola Sans i Alba Hernández Vidal

Data managers: Ruben Xavier Torres Ramos, Karen Castro Nuñez i Kateryn Pérez Medina

Phase 1 Nurse team: Vanessa Segura Zabalgo, Elica Alvarez Alvarez, Josep Oriol Parada González, Meritxell Chacón Guillermo i Raquel Luque Lázaro

UFF1 facilities (Functional Phase I unit)

  1. Monitoring Room (holds 4 monitors) with computers.
  2. Access to Electronic Medical Records for trial monitors.
  3. Freezers:
  • Freezer -86º : NIRCO NU-9668-E.
  • Freezer -20º:   LGUEX1500 (LIEBHERR)
  • Fridge laboratory:. VERTEX. LKV3913 (LIEBHERR)
  • Fridge laboratory:. VERTEX. LKV3913 (LIEBHERR)
  1. Electrocardiogram: EQUIMED CP150 WIFI Interpretation.
  2. Defibrillator: SINAMEDIC ZOLL R SERIES C/PACEMAKER SpO, PANI, EtCO.
  3. Centrifuge: EPPENDORF 5804 R, 230 V/5060 HZ with ROTOR S-4-72 .
  4. Monitor CSM: EQUIMED WIFI.
  5. Scale: Kern MPE 250K100HM.

 

Update:  13.03.2018