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 last year, 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 2021 they managed drugs used in 609 active clinical trials in oncology & hematology, and 11,719 resupply deliveries/clinical trial supplies receptions. Our cutting-edge 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-the-clock 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 2021 our dispensing staff actively participated in 280 pre-study visits, 280 initial visits, 2014 monitoring visits, 160 close-out visits, and also successfully passed 8audits, and 2 ISO inspection.
Additionally, 44,261 clinical trial drugs have been dispensed and validated by our pharmacists, 12,969 of which were for oral administration, 1,230 for IM/ subcutaneous administration, and 29,974 for IV administration. A total of 234 Standardized Dispensing Procedures for clinical trials have been drawn up and we have performed 985updates of these procedures due to subsequent amendments to protocols or pharmacy manuals. 103 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 29,974. We also included 363 antineoplastic therapeutic schedules in our prescription software.
Our Pharmaceutical Care Program for patients enrolled in phase I clinical trials: we performed 967 visits, 447 screenings, 967 C1D1s, and 1,050 follow-ups, also compiling patient diaries and/or instructions for patients (in the absence of documentation provided by the respective sponsor).
- 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, II and III studies treated with orally administered medicines to improve safety, compliance and the efficacy of these therapies.
- Successful sponsor audits as well as inspections carried out by regulatory authorities.
- 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.