The Clinical Research Oncology Pharmacy Unit is ISO 9001:2008 certified and is associated with the Medical Oncology Programs of the Vall d’Hebron University Hospital.

Our clinical research activities are carried out through two programs:

The Oncology Pharmaceutical Care Program is responsible for preparing cytostatics, monoclonal antibodies, biological products and other parenteral anti-tumor drugs used in clinical trials in oncology, as well as monitoring clinical activity in oncology patients. It incorporates a team of pharmacists specializing in hospital pharmacy and oncology pharmacy, as well as laboratory technicians.

The Pharmacological Research in Oncology Support Program comprises a team of pharmacists, biologists, nurses, and laboratory technicians specializing in clinical trials. The program is dedicated to managing, monitoring, issuing and controlling samples for clinical trials in oncology and its delivery to SC (oral medication) or to the Oncology Pharmacy Unit (IV infusion medication).


STRATEGIC GOALS

  • Excellence in services we provide to clinical oncology research programs through optimal efficacy, efficiency and safety.
  • Traceability of management and preparation of drugs for clinical trials.
    Preparation and administration of clinical trial drugs according to protocol specifications.
  • Maximize control of storage temperature of samples and preparations.
    Enhanced documented control of drugs returned by patients.
  • Provide a pharmaceutical care program for patients in Phase I trials with oral medication (to improve safety, compliance and efficacy of the treatment), as well as instructions and indications to patients for orally administered treatments in Phase II and III trials.
  • Final validation of a traceability program in clinical trial supplies management (storage, dispensation and accountability), to be enhanced through an interphase with the traceability program used in the Cytostatics and Monoclonal Antibodies Preparation Unit: ISISHTRI program.

CURRENT OBJECTIVES

  • Achieve excellence in the quality of the service we provide to the different clinical oncology research programs through optimal efficacy, efficiency and safety.
  • Ensure traceability of management and preparation of drugs for clinical trials.
  • Provide and ensure excellent control of the storage temperature of samples and products prepared.
  • Increase documented control of the accounting for drugs returned by patients.
  • Provide instructions and indications to patients for orally administered treatments.
  • Implementation of traceability program in clinical trial supplies management (storage, dispensation and accountability) and enhance through an interphase with the traceability program used in the cytostatics and monoclonal antibodies preparation Unit. ISISH-TRI program.
  • Prepare trial drugs for parenteral administration through integrating all phases of prescription, preparation and administration in computerized systems to prevent errors in medication.
  • Provide pharmaceutical care to patients enrolled in Phase I clinical trials to achieve optimal study treatment and increased patient safety during treatment.

MAIN ROLES & RESPONSIBILITIES

  • The management and delivery of clinical trial drugs.
  • Updating and improving our novel system for controlling storage temperature.
  • Implementation of a new safety drug accountability procedure for drugs returned by patients allowing either our unit’s personnel to perform drug accountability, or the sponsor to verify treatment compliance safely, using a Cabin Vertical Laminar FLOW (CVLF).
  • Ensuring traceability of storage management, custody, and dispensing of clinical trial drugs
  • Design and validation of the drug preparation process traceability system.
  • Support for, and liaison with, the trial sponsors.
  • Dispensing, preparations, and compiling documentation relating to each clinical trial for medical and nursing staff as well as patients.
  • Development of our pharmaceutical care program for patients included in Phase I clinical trials.
  • Improved pharmaceutical care of patients included in Phase I/II trials.

TEAM


  • Coordinator of the Clinical Research Oncology Pharmacy Unit
    • Maria Josep Carreras Soler
  • Coordinator of Pharmacological Research in Oncology Support Unit
    • Laura Mañós Pujol
  • Pharmacists
    • María Alcalde
    • Isabel de la Paz
    • Anna Farriols Danés
    • Celia Gonzalez
    • Inés Jiménez Lozano
    • Gloria Molas
    • Maria Oliveras
    • Eugenia Palacio
    • Berta Renedo
    • Núria Sabaté
    • Carol Valdivia Vadell
    • Jana Vidal Otero
  • Clinical Trials Re-Supplies Manager
    • Sara Pizarro López
  • Technicians
    • Romina Bellini
    • Elisabet Bordas
    • Esther Carabantes
    • Maria Hidalgo
    • Susana Mulet
    • Isabel Pérez
    • Marta Pozo
    • Gemma Tomás
    • Silvia Torralba
    • Esther Vilaró
    • Noemí Visús