CLINICAL TRIALS OFFICE

GEMMA SALA
Director


Set up in 1997, the Clinical Trials Office comprises an operational team conducting clinical trials at the Vall d’Hebron University Hospital’s Oncology Department with more than 35 professionals including study coordinators, data managers and administrative staff working on more than 280 trials. They are responsible for the logistics, coordination, data management and also the start-up process for new studies.

Each trial has an appointed coordinator and a data manager. Responsible for managing the procedures and assessments required in accordance with the protocol, the coordinator acts as the link between the study sponsor and the research team. The data manager provides the sponsor with all the necessary clinical data and monitors the quality of these data.

The Clinical Trials Office coordinates studies from phase I to phase III and is divided into three separate teams: Phase I, Breast Cancer, and Phase II-III.

In 2015 our office has conducted 289 actively recruiting trials and succeeded in recruiting and coordinating a total of 979 patients in these trials. In addition, we are following up all patients that were recruited prior to 2015 who are still enrolled and receiving study treatment. For annual evolution figures (1999 – 2015) please click here.

For more information about Phase I and early Phase II trials, please see  the Research Unit for Molecular Therapy of Cancer UITM – ”la Caixa”.


STRATEGIC GOALS

  • Contribute to the development of novel therapies against cancer.
  • Consolidation as an international reference hospital for clinical trials in oncology.
  • Guide patients taking part in a trial to comply with the requirements of the protocol and help them with daily life throughout this period.
  • Ensure that the protocol is appropriately conducted from initiation to the close of the respective trial.
  • Standardize clinical trial processes to ensure optimal quality and the compliance of Good Clinical Practice (GCP).
  • Provide high quality data adhering to deadlines.
  • Facilitate the work and communication between the different staff involved in each trial (oncologists, nurses, pharmacists, pathologists, etc.).
  • To prepare for and successfully pass audits carried out by sponsors and regulatory agencies.
  • Organize an annual post-graduate course of clinical trials in oncology to train study coordinators, data managers, nurses and CRA’s.
  • Maintenance of patient data software for clinical trial management and data exploitation (annual statistics, patient activity, etc.).

CURRENT OBJECTIVES

  • Increase the number of patients enrolled in clinical trials Phase I,II and III.
  • Increase the number of clinical trials performed.
  • Provide tailored training to our staff in order to improve the quality of their work and expand upon skills.
  • Implement new tools and procedures aimed at increasing the quality and efficacy of research.

TEAM


Director

  • Gemma Sala

Head, Clinical Trials Office for Phase I Trials

  • Gemma Sala

Study Coordinators

  • Sonia Abad
  • Eulalia Aliende
  • Ainhoa Balague
  • Raquel Blanco
  • Luisa Carbonell
  • Raquel de La Torre
  • Maria Garcia
  • María Herranz
  • Sonia Martínez
  • Lidia Martínez de Arenzana
  • Laura Maynés
  • Montserrat Moreno
  • Gemma Mur
  • Mireia Sole

Data Managers

  • Ignacio Carcela
  • Marina Coll
  • Giovanni de Marino
  • Gloria García
  • Marta Monserrat
  • Isabel Rico
  • Rosa Maria Romero

Head, Clinical Trials Office for Phase II-III Clinical Trials (GI, Lung, Head & Neck, and Gyne)

  • Mara Beltran

Study Coordinators

  • Carlot Aguilera
  • Alejandra Caballero
  • Iris de La Fuente
  • Iris de la Fuente
  • Elena Fernandez
  • Patricia Garcia
  • Cristina Perez
  • Sergi Recasens
  • Andrea Retter
  • Eulalia Scheenaard
  • Sandra Tijeras

Data Managers

  • Izar Achaerandio
  • Laia Gregori
  • Raque Gutierrez
  • Eva Mª Lazaro
  • Silvia Marin
  • Sergio Pérez
  • Julia Serra

Head, Clinical Trials Office for Phase I-III Cancer Trials (Breast, GU, CNS, Sarmcoma, and GIST)

  • Meritxell Soler

Study Coordinators

  • Judith Alonso
  • Enric Alvarez
  • Beatriz Bruno
  • Serigio Fernandez
  • Carlos Fernandez
  • Berta Garrido
  • Alba Meire
  • Thais Miquel
  • Olga Padrós
  • Mariona Pocarull
  • Angela Quintana
  • Ester Serra
  • Anna Serrano

Head, Clinical Research Support Unit (CRSU)

  • Susana Muñoz

Masters Student CRSU

  • Ana Radakovic

Sample Managers

  • Cristina Resina
  • Gemma Pruna

Data Managers

  • Cristina Aguilar
  • David Alvarez
  • Marta Batista
  • Maria Isabel Martinez
  • Carina Monclús
  • Nuria Ortega

Clinical Trials Assistants

  • Núria Carballo
  • Cristina Garcia
  • Marc Palomar

Quality Assurance Manager

  • Silvia García