Organization - Clinical Pharmacology Service

Clinical Research Support Unit.  The Unit aims to promote and strengthen clinical research carried out at the Campus Clínic. The Unit offers methodological, ethical, and regulatory support and management, through an integrated structure of services that guarantee the highest quality standards. This support facilitates the efficient and competitive performance of studies.
It offers guidance throughout all phases of clinical research, from project design, management, and monitoring to data analysis and the presentation of results. It also provides tools to ensure compliance with regulatory requirements, Good Clinical Practice, and data quality.

Indicators: The Unit has participated in the initiation, conduct, monitoring, data management and statistical analysis of over 500 clinical research projects involving drugs and medical devices, and responds to over 100 annual enquiries regarding methodology, ethics, regulation, and clinical trials thorough a one-stop shop.

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The Research Support Unit leads:

• Medical Statistics is an IDIBAPS platform linked to the Clinical Pharmacology Department, which offers methodological, statistical, and IT support to clinical research projects, both at the Campus Clínic and in other research centres and private companies. The platform promotes clinical research excellence, collaborating on more than 20 publicly funded projects and research networks (ECRIN, SCReN), and contributions to the Ethics Committee and the Clinical Pharmacology Department’s One-Stop Shop. It also participates in scientific activities and teaching on methodologies and statistics. Medical Statistics provides consulting on statistical design, data collection (eCRD), statistical analysis, and database creation for clinical trials, ensuring traceability and compliance with regulatory requirements.
   
• Clinical Trials Unit (CTU) in the Clinical Pharmacology Department aims to support and promote clinical research conducted within and by the Institution, driving research through an integrated service structure that guarantees the highest ethical, scientific, and quality standards to conduct studies efficiently and competitively. Its affiliation with the Campus Clínic enables close and ongoing collaboration with all stakeholders involved in research projects, promoting and optimizing the integrated management of each project phase.
  
  The Unit carries out tasks related to the promotion and conduct of clinical trials involving advanced drugs and therapies, medical devices, and other research projects, ensuring compliance with the current regulations, Good Clinical Practice guidelines, and quality standards. Its design focuses on the design, drafting of protocols, submission to regulatory authorities, coordination, monitoring, pharmacovigilance, and preparation of clinical reports for Phase 1-4 multicentre clinical trials across various clinical specialties, both nationally and internationally.
  
  Over the past 25 years, it has participated in the conduct of more than 200 projects that have recruited nearly 50,000 patients. The Unit is also dedicated to the national coordination of publicly funded clinical trials, as part of the ISCIII (Carlos III Health Institute) clinical research support platforms (SCReN), and the European platform (European Clinical Research Infrastructures Network, ECRIN).

Technical Secretariat of the CEIm. The Technical Secretariat of the Research Ethics Committee for Medicinal Products (CEIm) is made up of professionals from the Clinical Pharmacology Department. It is a technical and administrative structure that coordinates and carries out the functions of the CEIm at the Hospital Clínic de Barcelona. Its main activity is to ensure the smooth administrative and technical operation of the management and evaluation of projects and clinical trials. The Secretariat is responsible for the entire process: receipt, administrative and technical management, document organization, evaluation, and issuance of opinions on studies reviewed by the CEIm.
In addition, it offers administrative and practical consultation services to researchers, providing support in the admission, management, and ethical and methodological evaluation of projects and clinical trials.

Indicators: The Technical Secretariat of the CEIm manages and processes approximately 1,000 research project applications, 50 clinical trials involving drugs, 80 clinical investigations involving medical devices, 100 observational studies involving drugs, and 350 amendments for evaluation by the CEIm each year. 

Advanced Therapies Regulation Group. The main activity of the Advanced Therapies Regulation Group is to design the regulatory strategy for the Hospital’s advanced therapy products, including the CAR T-cell therapies in the ARI project, in order to facilitate their transition from clinical research to authorization for hospital use. The group is responsible for coordinating all scientific documentation submitted to the relevant regulatory agencies and has actively participated in the clinical development of cell and gene therapies, in both the academic and biotechnology sectors. Moreover, it offers consulting services for early-stage projects and is responsible for reviewing and managing regulatory documentation. The group is also part of the Functional Unit for Cellular Cancer Immunotherapy, created in 2023, with the aim of coordinating anti-tumour adoptive cell immunotherapy at the Hospital Clínic de Barcelona, as well as managing collaborative projects with other public and private institutions.

Indicators:

• Regulatory collaboration on 15 active projects with CAR T-cell therapy, with 5 projects currently in the early stages of development.
• Coordination with more than 15 scientific consultations with regulatory agencies (EMA and AEMPS).
• Preparation, coordination, and processing of 2 authorizations for hospital use of non-commercially manufactured CAR T-cell therapies.

Pharmacovigilance. Pharmacovigilance is the discipline responsible for detecting, evaluating, and preventing adverse events or adverse reactions related to medications. The pharmacovigilance professionals carry out key activities such as the Clinical Pharmacovigilance Programme, which monitors drug safety at the Hospital. In addition, they collaborate with the Vaccine Functional Unit, created in 2024, to promote vaccination coverage and monitor adverse effects. They also conduct pharmacovigilance for advanced therapies such as CAR T-cell therapies. The group participates in international clinical trials in accordance with Good Clinical Practice and Good Pharmacovigilance Practice, and trains healthcare professionals and students in the detection and management of adverse reactions.

Indicators: More than 750 suspected adverse reactions received through the Clínic Pharmacovigilance Programme have been evaluated (over 300 reported to regulatory agencies), and approximately 200 reports are evaluated annually. Coordination of pharmacovigilance in clinical trials and participation in vaccine projects.