LEstablished in 1997, our Clinical Trials Office incorporates experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, the Vall d’Hebron Barcelona Hospital Campus. Headed by VHIO’s Director, Josep Tabernero, our team comprises study coordinators, data managers and administrators who coordinate phase I–IV clinical studies and also participate in several translational research projects at VHIO.
Organized into 4 groups (start-up unit, oncology study coordinators, oncology data entries, hematology study coordinators and data entries) covering all tumor types and studies, this team is managed by our Clinical Trials Office Director, Marta Beltran.
Clinical Trials in Oncology
In 2021 we managed 4 phase 0, 180 phase I, 27 basket, 153 phase II, and 147 phase III clinical studies with active recruitment throughout the year (Figure I), with patient enrolment totaling at 1,326 (Figure II). 183 new trials were initiated, including 12 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2021 and are still enrolled and receiving study treatment (890 patients in total, and 2016 in follow-up).
More than half of our patients included in our phase I clinical trials have been referred to us from other hospitals, which has consequently positioned our Unit as a leading reference in early clinical studies. Reflective of our recognized excellence, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, directed by Elena Garralda, has been re-accredited by the Generalitat de Catalunya (Government of Catalonia).
As we continue to render personalized medicine more precise by matching therapies to the specificities of each individual patient, each individual tumor, the requirements and selection criteria for inclusion in certain studies are becoming more complex.
We are dedicated to expanding our portfolio of trials in to ultimately establish new treatment models with highly selective drugs. Our Unit continues to fine-tune patient selection criteria in order to identify those patients who are most likely to benefit from novel therapies, including emerging immune-based treatments, tailored to individual patients’ molecular ‘measurements’.
Clinical Studies in Hematology
In 2021 we managed 49 phase I, 2 basket, 35 phase II, and 60 phase III clinical trials with active recruitment throughout the year (Figure III) with patient enrolment totaling at 182 patients (Figure IV). 67 new trials were initiated, including 6 post-authorization trials, and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2021 and are still enrolled and receiving study treatment (140 patients in total, and 105 in follow-up).
The prestige of HUVH's Medical Oncology Department, led by VHIO's Director, Josep Tabernero, is recognized by pharmaceutical and biotechnology companies. It has also become a reference program and selected by the industry to carry out complex clinical trials. The number of participating centers in these studies is highly restricted.
Clinical sites are selected based on the highest quality standards and capacity for carrying out state-of-the-art research. We have participated in early phase trials of different drugs, ultimately enabling the pharmaceutical industry to market novel anti-cancer medicines. We are involved in studies promoted by the pharmaceutical industry as well as those developed by us in collaboration with other hospitals. In 2021, we also conducted more than 16 investigator-Initiated trials (IITs) in oncology.
Contribute to the development of novel therapies against cancer.
Consolidation as an international reference for clinical trials in oncology and hematology.
Guide patients enrolled in clinical trials to comply with the protocol requirements and help them with daily life throughout the duration of their participation.
Standardize clinical trial processes to ensure optimal quality and the compliance of Good Clinical Practice (GCP).
We continue to report important numbers of clinical trials performed and respective
Optimal management of complex protocols which are increasingly demanding.
Implementation of new tools and procedures to increase the quality and efficiency of research.
Reorganization of our Clinical Trials Office to implement transversal projects.
RESEARCH UNIT FOR MOLECULAR THERAPY OF CANCER (UITM) – CaixaResearch
Principal Investigator of VHIO’s Early Clinical Drug Development Group
Director, Research Unit for Molecular Therapy of Cancer (UITM) “la Caixa”
Medical Doctor’s Degree. Universidad Autónoma de Madrid, Madrid.
Medical Oncology Specialization. Hospital Universitario 12 de Octubre, Madrid. 2011.
Master’s Degree in Molecular Oncology. Centro de Estudios Biosanitarios (CEB), Madrid.
Management Fundamentals and Skills for Scientists and Researchers. IE Business School, Madrid. 2013.
ECFMG Certification – Educational Commission for Foreign Medical Graduates. USA, 2012.
DEA, Advanced Studies Diploma. Universidad Complutense de Madrid, Madrid.
Joint ECCO-AACR-EORTC-ESMO workshop on methods in clinical cancer research (Flims), Switzerland.
Areas of Research
Early Drug Development
Mainly focused on proof-of-concept and proof-of-mechanism trials with targeted therapies with special emphasis on those in cell signaling, cancer stem cells, and immuno-oncology as well as epigenetics.
First-in-human studies of targeted therapies, rational combinations of targeted therapies, biomarker-driven trials, and trials in molecularly selected populations.
Linking clinical research at VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch with the different areas of investigation carried out at our Institute such as the molecular analysis of patients’ tumors and molecular prescreening, as well as developing novel diagnostic tests (e.g. circulating DNA; Nanostring) with marketable pathways to select the best anti-cancer therapy or drug-drug combinations – covering some of the most promising targets in immune checkpoints and cytokines -matched to the aberrations of individual tumors.
Converging immuno-oncology and genomics to further advance precision medicine against cancer, and aim at expanding research in epigenetics
Scientific Committees & Advisory Roles
ESMO – Women for Oncology. Committee Member. 2017.
ESMO - Faculty Member. 2020.
ESMO - Drug Development Therapeutics Track – Committee Member & Chair. 2018.
Evaluation Committee – CLIPP Labellisation 2019-2024, Institut National de Cancer, Paris. 2018.
Comité Evaluador IDEA2 Madrid, MIT (Massachusetts Institute of Technology) – M+Vision Consortium.
AACR - NextGen Grants for Transformative Cancer Research Scientific- Evaluator Committee Member. 2020.
Partners of Choice Joint Network Committee, MedImmune, Maryland.
imCORE – Immunotherapy Centres of Research Excellence Network Translational Committee, Roche.
Clinical Trials Task Force – Leader. Cancer Core Europe Consortium (CCE). 2019.
Reviewer for Annals of Oncology, ESMO.
Reviewer for Cancer Treatment Reviews, Elsevier.
Reviewer for British Journal of Cancer, BJC Editorial Office.
Reviewer for JAMA Oncology.
Reviewer for Clinical Cancer Research, Lancet Oncology,Nature Reviews, ESMO Open, Cell Reports.
Prizes and Scholarships
TxSCO – Fellows Abstract Award, Texas Society of Clinical Oncology.
Inaugurated in June 2010, thanks to the support received from the ”la Caixa” Foundation, VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch is dedicated to complex clinical trials with drugs in early development (phase I and early phase II trials), focusing on novel targets. Occupying a total surface area of 1000 m2, our Unit is located within the General Area of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus.
This privileged environment with direct access to patients, coupled with VHIO’s translational approach to research and superb scientific framework, has enabled our Unit to rapidly establish itself as one of the few comprehensive facilities in Europe to rapidly transform latest discovery into benefits for patients. Our UITM – CaixaResearch incorporates a multidisciplinary team comprised of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel.
By promoting tight connectivity between oncology care and research we establish novel treatment models for patients with highly selective drugs, and advance insights into tumor types and how to treat them in an individualized way – getting the right therapy to the right patient, at the right time. As the statistics show, we continue to do so for an increasing number of patients.
For another year, we have had to rapidly adjust to overcome the many challenges posed by the COVID-19 pandemic. All our efforts have focused on successfully maintaining our clinical research activities and continuing to include patients in our clinical trials. During 2021, our Unit participated in 207 ongoing phase I clinical trials, 27 of which are Basket trials (a 6% increase compared with 2020).
Our facilities, coupled with our multidisciplinary clinical teams, enable us to continue to expand our portfolio of phase I studies with 551 patients enrolled (a 6% increase compared with 2020). This year we opened 66 new trials; 5 as Baskets.
Research carried out at our Unit by VHIO’s Early Clinical Drug Development Group, directed by Elena Garralda, centers on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimens using combinations of new agents with those that already exist.
Reflective of VHIO’s purely translational model, our studies are also linked to several research lines led by other VHIO groups, thus connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists collaborate in our trials to facilitate biomarker development, a deep understanding of the mechanism of action, as well as research into mechanisms of cancer drug resistance.
We also participate in VHIO’s Molecular Prescreening Program, that performs molecular analyses of patients’ tumors to select the best possible treatment with the experimental therapeutics available. Thanks to our Cancer Genomics Group (PI: Ana Vivancos) and their development of existing applications including an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and two NextGen Sequencers; MiSeq and HiSeq2500 (Illumina), we are equipped to perform faster and more precise mutational analyses of tumor suppressor genes as well as translocations and gene amplifications.
Excellent patient treatment and care as well as pioneering research is also made possible thanks to the collaboration of many other oncology professionals including our team of Clinical Research Oncology Nurses led by Ángeles Peñuelas, pathologists from the Vall d’Hebron University Hospital’s Molecular Pathology Department, radiologists and interventional radiologists, our Clinical Trials Office directed by Marta Beltran, Database Managers, VHIO’s Clinical Research Oncology Pharmacy Unit headed by Isabel Cidoncha, our Quality & Processes Unit headed by Gemma Sala, as well as many other healthcare specialists including dermatologists, cardiologists, and ophthalmologists.
Early clinical drug development and translational research led by our UITM – CaixaResearch clinical investigators and VHIO researchers: expansion of our broad portfolio of promising novel anticancer therapies, across a balanced spectrum of studies, with special focus on first-in-human studies, novel-novel combinations, best-in-class compounds, and a new class of drugs.
Perform complex trials such as organ dysfunction trials, Octopus as well as Basket studies, and link clinical research at this Unit to VHIO's preclinical and translational projects. We also collaborate with various other partners involved in drug development and translational research.
Genomic medicine trials in early drug development: perform molecular analysis of patients' tumors in order to select the best possible treatment with the experimental treatments available, co-develop medical informatics applied to genomic medicine, and integrate preclinical and clinical research by incorporating novel drugs, new insights, and study design together with customized molecular diagnostics.
Immunotherapy: our Unit's Task Force in early drug development of immunotherapeutics and cell signaling focuses on second generation immunotherapies, including new cytokines, bispecifics, intratumoral agents, immunomodulatory, and immune checkpoint inhibitors and combinations, as well as translational research in immuno-oncology.
We have performed some of the most complex phase I trials, including those focused on molecularly-selected patient populations (trials in complex molecularly-selected patient populations Basket/Octopus trials), as well as trials in immuno-oncology.
We have expanded our expertise in drugs targeting developmental pathways, cell signaling (ERK, MET, FGFR, RET, NOTCH, NTRK), and immunotherapy (LAG3, TIGIT, OX40, CD40, IDO, arginase inhibitors and engineered antibodies).
Developed by VHIO's Cancer Genomics Group (PI: Ana Vivancos) we benefit from applications that enable us to generate faster results. These include an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and two NextGen Sequencers; MiSeq and HiSeq2500 (Illumina). We also co-develop customized molecular tests for VHIO's Molecular Prescreening Program, namely, disease-oriented mutation panels for our NGS platforms.
We have established alliances with several pharma companies as the preferred site for testing their novel and most relevant therapies, including GlaxoSmithKline OCTC, Roche ImCORE, and Astra Zeneca/MedImmune Partner of Choice Network.
Our investigators have successfully implemented the Basket of Baskets (BoB) trial which is a novel study in personalized medicine integrating cutting-edge molecular prescreening, the development of new diagnostic tests such as circulating DNA or Nanostring, with the testing of targeted therapies in populations of patients with identified molecular alterations and a high probability of benefiting from the selected treatments. This is an academic study, endorsed by the Cancer Core Europe (CCE) Consortium, and co-funded by pharmaceutical companies. We are engaged in ongoing and advanced negotiations with pharmaceutical companies to increase the number of modules.
We have introduced Molecular Tumor Board meetings to discuss the most relevant genomic features of complicated cases and evaluate possible treatment options.
We have launched an advanced cell-based therapy program, and are participating in several pharma sponsored trials to evaluate the role of TIL therapy. We are also exploring an academic TIL product in collaboration with Alena Gros (PI: VHIO’s Tumor Immunology & Immunotherapy Group).
In collaboration with several other VHIO groups, we head our CaixaResearch Advanced Oncology Research Program (2020-2023), also supported by the ”la Caixa” Foundation.
Mª Angeles Peñuelas
Clinical trials in oncology are essential for developing novel, more effective targeted therapies against cancer as well as improving survival, side effect profiles and the quality of life of our patients. Advances in oncology care and the delivery of more powerful anti-cancer medicines are driven by optimal processes in clinical trials.
Our expert clinical research oncology nurses assume a central role by undertaking a variety of tasks including identifying trends in side effects, and closely collaborating with multidisciplinary teams to develop and evaluate patient management. They contribute to clinical studies by collating samples and quality data, as well as provide excellence in nursing care and optimal symptom management for all patients enrolled in our clinical trials.
The COVID-19 pandemic continued to pose challenges in 2021, which naturally demanded adaptive procedures, circuits and structures. Where possible, our clinical groups and oncology nurses had, in many cases, to continue to re-think conventional patient care. With the safety of our patients as the highest priority, Angeles Peñuelas led her team to work together with VHIO’s medical oncologists and clinical investigators to swiftly establish adaptive approaches to ensure the optimal running of clinical studies, while delivering the highest levels of quality patient care.
Newly introduced measures throughout the COVID-19 waves –whenever/wherever possible- included remote monitoring as well as dispensation of medication for certain patients receiving orally administered therapies, and telematic clinical consultations.
VHIO's clinical research oncology nurses are specialized in molecular therapies and represent an essential element of the multidisciplinary teams involved in the studies performed and coordinated at VHIO's Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch and Clinical Trials Office, directed by Elena Garralda and Marta Beltran, respectively.
Supporting these teams comprised of medical oncologists, molecular pathologists, oncology pharmacists, clinical researchers, and study coordinators, VHIO's oncology nurses are key to ensuring the delivery of optimal care for our patients who receive the full range of expertise, guidance, and the necessary follow-up throughout the course of their participation in clinical studies. As importantly is the psychological support that they provide, alongside the other superbly trained oncology care givers and specialists, including psychologists.
Our nurses also provide patients and their families with the information and professional guidance required to make fully informed decisions concerning their treatment options. In 2021, across the 511 actively recruiting trials in oncology, patient enrollment totaled at 1,326. Regarding clinical studies in hematology, across the 146 active trials, a total of 182 patients were enrolled. Our clinical teams also continue to follow up patients that were recruited prior to 2021 who are still enrolled and receiving treatment.
VHIO continues to expand its portfolio of clinical trials to establish novel treatments with highly selective drugs, as well as fine-tune patient selection criteria in order to identify those patients who are most likely to benefit from them. We can expect a steady increase in patient recruitment across our clinical studies in the future.
Clinical Research Oncology Pharmacy Unit
Clinical Director of the 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 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
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.
Molecular Prescreening Program
FERO Foundation Advanced Molecular Diagnostics Program (DIAMAV)
VHIO's Molecular Prescreening Program, driven by FERO’s Institutional Advanced Molecular Diagnostics Program – DIAMAV, catalyzes precision medicine at VHIO. Over the last decade, this program has provided access to advanced molecular diagnostics to more than 8,000 cancer patients, and is critical in matching targeted therapeutic approaches with hundreds of clinical trial opportunities.
This program, also counting on the support and expertise provided through our Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, is co-led by VHIO’s Ana Vivancos, Paolo Nuciforo, Elena Garralda (also Director of the UITM), and Rodrigo Dienstmann, Principal Investigators of our Cancer Genomics, Molecular Oncology, Early Clinical Drug Development, and Oncology Data Science (ODysSey) Groups, respectively. Activities are coordinated by Susana Aguilar, Head of our recently created VHIOTECA Unit, in collaboration with Jenifer González, Research Support Technician (VHIO’s Cancer Genomics Group).
The main objective of molecular prescreening at VHIO is to facilitate the clinical implementation of emerging cancer biomarkers that help to optimize the selection of therapies for patients being considered for enrollment in clinical trials. Our program guides clinicians in selecting both standard-of-care and investigational anti-cancer treatments and spurs clinical-molecular correlative research at VHIO. Diagnostic tests are developed and validated in-house for the cost-effective and streamlined identification of tumor molecular alterations of major interest in drug development.
Tumor profiling includes a variety of genomic techniques including next-generation sequencing panels (NGS) for the detection of mutations, copy number variations, gene fusions and RNA expression signatures, as well as histopathological techniques such as immunohistochemistry (IHC) and in situ hybridization (ISH) for protein and gene expression profiling.
In 2021, we have performed tumor molecular profiling in 1,138 cancer patients that are candidates for enrollment in clinical trials.
Interpretation of next-generation sequencing tests and educating clinicians on emerging biomarkers is another of our priority areas. During Molecular Tumor Board and Genetic Tumor Board meetings, we facilitate data exchange among a broad range of experts for the review of patients’ medical histories and cancer molecular profiles in order to more precisely guide treatment decisions and preventive measures.
Clinical implementation of advanced molecular diagnostics to optimize the selection of therapies for patients being considered for enrolment in clinical trials.
Continued medical education with standardized reports of genomic alterations and weekly Molecular Tumor Boards.
Constant revision and update of molecular diagnostic tests to cover emerging cancer biomarkers for precision cancer therapy.
VHIO is an active member of the AACR Genomics Evidence Neoplasia Information Exchange (GENIE) project, a multi-phase, multi-year, international study that catalyzes precision oncology through the development of a regulatory-grade registry aggregating and linking clinical-grade cancer genomic data with clinical outcomes from tens of thousands of cancer patients treated at the participating institutions.
Our VHIOTECA Unit was created in 2021 to support researchers for the obtention, registration and preservation of biological samples other than tumoral tissue (plasma, feces, saliva, etc.) from cancer patients, and facilitate the use of these samples in research projects.
The use of liquid biopsy testing in cancer patients for the identification of new biomarkers of response and resistance to therapy, coupled with its incorporation in clinical research projects requiring plasma, have led to a significant increase in the extraction of blood samples from cancer patients.
This activity requires a suitable structure, dynamization of circuits and the optimization of resources. For this reason, our first objectives are to consolidate existing circuits and processes so that they are consistent and reliable, and to ensure the optimal use of samples in the best possible conditions. We are also committed to supporting VHIO researchers in setting up new projects and collaborations that require the use of these types of samples.
Another area of growing interest of research in clinical oncology is the study of the microbiome during tumor development and progression, especially in colorectal cancer. These studies require the collection and genomic and molecular analysis of stool samples as well as the completion of questionnaires for subsequent epidemiological studies. To support our researchers, we aim to create a new sample and data collection circuit that facilitates the development and execution of projects.
Our team comprises clinical research oncology nurses specialized in specific tumor types, technical staff for sample processing and registration (sample managers), and technical support staff for sample logistics and management, database creation and maintenance.
Provide support to researchers in the extraction, registration and storage of samples (mostly plasma) and database maintenance.
Standardize protocols and establish Standard Operating Procedures (SOPs).
Maintain optimal registration and archiving of the informed consent of the patients.
Creation and consolidation of new circuits: establish new circuits for the collection of different plasma and tumor samples (e.g. feces, saliva, breast milk, etc.), sample and patients’ data, and tailor them accordingly to meet the requirements and specificities of research projects.
Research support: collaborate with different teams of clinical and preclinical researchers to help set up new projects and collaborations using existing or new samples.
Active participation in the following international projects:
EUCANCan: a federated network of aligned and interoperable infrastructures for the analysis, management and homogeneous sharing of genomic oncology data for Personalized Medicine.
Molecular Tumor Board (MTB) of the Cancer Core Europe (CCE) Consortium’s Baskets of Baskets (BoB).
Genomics Evidence Neoplasia Information Exchange (GENIE) Project of the American Association for Cancer Research (AACR).
Quality & Processes Unit
Headed by Gemma Sala, VHIO’s Quality & Processes Unit was established in 2020 to further improve quality and unify processes in clinical trials carried out at VHIO.
Our Unit is made up of quality, and transversal support teams including sample managers and schedulers.
We perform numerous tasks related to clinical trials and all of our activities are carried out by assuring excellent quality, ensuring that the processes governing them are both optimal and homogeneous.
Quality is of parmount importance in performing clinical trials. Guaranteeing that all the current regulations of these studies are complied with is therefore essential. These homogeneous efforts follow Good Clinical Practice (GCP) guidelines, with the safety of patients as the top priority throughout.
Cross-support and common clinical trial tasks including scheduling, sample management,
and the direction of quality and processes.
Collaborate with all teams participating in our clinical trials, detecting non-conformities
and making improvements from the very outset.
Promote prevention versus correction to ensure that the methodologies and
Successfully pass all audits and site inspections.
Standardize processes and generate a good flow of communication between teams, as a key operating element.
Carry out periodic and predefined quality controls relating to documentation, circuits
Conduct regular training sessions to review and further enhance quality.
Renew and improve the implementation and development of the Government of Catalonia’s Certification of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch.
Develop and update Standard Operating Procedures (SOPs) to standardize circuits, and provide all necessary trainings.
The organization of in-house courses: Good Clinical Practice (GCP), revision of electrocardiogram (ECG), cardiopulmonary resuscitation (CPR).
Clinical trials in oncology and hematology.
Our Unit has collaborated in more than 600 active trials and we have successfully passed 17 audits and 3 inspections in 2021 (the Government of Catalonia’s inspection of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch, and inspections conducted by the European Medicines Agency – EMA, and the Food and Drug Administration – FDA).
We have actively participated in the revision and improvement of circuits, detecting incidents and proposing corrective actions, and in the homogenization and optimization of processes.
We have also collaborated in the internal training of staff involved in clinical trials.