Clinical Research Oncology Pharmacy Unit

Our Unit is ISO 9001:2015 certified and is part of the Medical Oncology Department of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus.

It is thanks to the funding received from the ”la Caixa” Foundation, that our new Facility, the Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch Clinical Research Onco-Hematology Unit opened in 2020. Equipped with all the very latest technologies, it enables us to provide even higher quality in pharmaceutical care and continue to respond to all regulatory requirements.

We focus on two main areas of clinical research in oncology:

Oncology Pharmaceutical Care Program

Our team of expert pharmacists are specialized in hospital and oncology pharmacy. The Unit’s laboratory technicians prepare cytostatics and other parenteral therapies used in clinical trials, as well as closely monitor and follow-up our patients.

Pharmacological Research in Oncology Support Program

This program is directed by our team of pharmacists and laboratory technicians specialized in clinical trials. They are responsible for the management of study supplies including storage, dispensation, and traceability control. In 2020 they managed drugs used in 591 active clinical trials in oncology & hematology, and 10,748 resupply deliveries/clinical trial supplies receptions. Our cuttingedge system for controlling storage temperature -performing electronic temperature recordings every 5 minutes daily- displays readings on computers equipped with audiovisual alarms as well as an around-theclock SMS alert system for monitoring and reporting temperature deviations. Regarding the design and validation of our Unit’s drug

preparation process traceability system, we ensure qualitative and quantitative quality control of our computerized system.

In 2020 our dispensing staff actively participated in 240 pre-study visits, 245 initial visits, 1,850 monitoring visits, 180 close-out visits, and also successfully passed 5 audits, and 1 ISO inspection. Additionally, 44,136 clinical trial drugs have been dispensed and validated by our pharmacists, 13,044 of which were for oral administration, 984 for IM/ subcutaneous administration, and 30,108 for IV administration. A total of 204 Standardized Dispensing Procedures for clinical trials have been drawn up and we have performed 684 updates of these procedures due to subsequent amendments to protocols or pharmacy manuals. 156 storage temperature data reports have also been prepared by our dispensing team.

Preparations of cytostatics, monoclonal antibodies and other parenteral antitumor drugs for clinical trials totaled at 30,108. We also included 392 antineoplastic therapeutic schedules in our prescription software. Our Pharmaceutical Care Program for patients enrolled in phase I clinical trials: we performed 1,248 visits, 348 screenings, 450 C1D1s, and 450 follow-ups, also compiling patient diaries and/or instructions for patients (in the absence of documentation provided by the respective sponsor). We have also compiled 20 different diaries and 28 instruction manuals for patients enrolled in the phase I studies involving orally administered drugs by our preparation staff. We also prepared 24 diaries and 80 patient manuals for phase II and phase III clinical trials in 2020 for patients enrolled in all phase II and III studies involving orally administered drugs by our dispensing staff.

Isabel Cidoncha
Clinical Director of the Clinical Research Oncology Pharmacy Unit
Maria Queralt Gorgas
Coordinator of the Clinical Research Oncology Pharmacy Unit
  • Excellence in the services that we provide to clinical oncology research programs through optimal efficacy, efficiency and safety.
  • Management, dispensing, preparation and administration of clinical study drugs according to protocol specifications. Ensure traceability of the entire circuit with the development and implementation of new software.
  • Maximized control of storage temperature of samples and preparations.
  • Optimal use of a computerized program, IPharma-FUNDANET®, for the management of clinical trial supplies.
  • Provision of a pharmaceutical care program for patients in phase I studies treated with orally administered medicines to improve safety, compliance and the efficacy of these therapies.
  • Provide instructions and indications to patients for orally administered therapies in phase II and III studies.
  • Successful sponsor audits as well as inspections carried out by regulatory authorities
  • Thanks to the support received from the ”la Caixa” Foundation, we moved into our new facility, the Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch- Clinical Research Onco-Hematology Unit. Equipped with cutting edge technologies, it enables us to provide even higher quality pharmaceutical care and continue to meet all regulatory requirements.
  • Replacing paper medical orders, we have implemented electronic prescription ordering for IV administration medication in our site prescription software.
  • We have developed new traceability software that includes global pharmacotherapeutic processes; the prescription, validation, dispensing, preparation and administration of drugs in the oncology and hematology clinical trial setting.
  • Our Unit provides clinical and technical support for the prescription, preparation, and administration of cytostatics in clinical trials, as well as e-records of usage and timings.
  • Qualitative and quantitative quality control of all parenteral anticancer preparations to guarantee patient safety and protocol compliance.
  • ISO9001:2015 certification renewed. Successful sponsor audits, regulatory inspections, and participation in the renewal of VHIO’s Phase I Unit reaccreditation.
Clinical Director of the Clinical Research Oncology Pharmacy Unit
Isabel Cidoncha
Coordinator of the Clinical Research Oncology Pharmacy Unit
Maria Queralt Gorgas
Pharmacists
María Queralt Gorgas, Carla María Esteban, Pablo Latorre, Eugenia Serramontmany, Montserrat Carreres, Patricia Ortega, Pilar Rovira, Javier Varela, Lorena García, Celia Fernández, Carlota Barón
Technicians
Marta Pozo, Susana Inés Mulet, Angelica Cely, Romina Bellini, Rafael Díaz, Esther Carabantes, Silvia Torralba, Roser Klimt, Alan Paul Thompson, Ariadna Javalera, Isabel Pérez, Noemí Visús, Alexandre Valle, Madiha Shaheen
Secretary
Isabel Mª Alerany
Data Entry
Carmen Torres