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QUALITY AND PROCESSES UNIT

QUALITY AND PROCESSES UNIT

GEMMA SALA
Director
gsala@vhio.net

  • Degree in Biology from the University of Barcelona.
  • After completing the Master in Clinical Trials Monitoring at the Col. legi de Metges in Barcelona, she joined the oncology service as coordinator of clinical trials in 2003.
  • She occupies the position of Head of the Office of Clinical Trials in Phase I between the years 2007-2016 and subsequently assumes the Direction of the Office until April 2020.
  • Postgraduate course in Quality Systems in Pharmaceutical Industry and Research at the UB.
  • In April 2020 she is proposed to lead the new Quality and Processes Unit.

WHO WE ARE?

The quality and processes unit was created to improve quality and unify processes in the clinical trials carried out by the VHIO.

It is made up of the quality team, and the Sample Management and Scheduler teams, which provide transversal support to clinical trials.

VHIO has numerous active tests, so it is very important to ensure that these tests and the personnel who perform them are within a framework of quality and excellence and the processes that govern them are optimal and homogeneous.

Quality is a key element for the correct performance of clinical trials, thus ensuring that current regulations governing CT are complied with, that homogeneous work is carried out that follows Good Clinical Practices and that patient safety is ensured throughout moment.


HIGHLIHTS

  • 2019 data in oncology and hematology clinical trials: more than 500 active trials; more than 1,200 patients included; monitoring and managing around 200 patients in treatment each month; 18 audits and 1 inspection.

OBJECTIVES

  • Cross-support common clinical trial tasks such as test scheduling, sample management, and quality and process management.
  • Carry out joint work with all the teams participating in the clinical trials, detecting non-conformities and applying points of improvement from the beginning of each study.
  • Promote prevention versus correction, and thus ensure that methodologies and improvements are established in the way of conducting clinical trials at VHIO.
  • Successfully pass the audits and inspections carried out in clinical trials.
  • Standardize processes and generate a good flow of communication between teams, as a key operating element.
  • Carrying out periodic and predefined quality controls, related to documentation, circuits and procedures.
  • Conducting regular training sessions to review and strengthen quality and improvement aspects.
  • Renewal and correct implementation and development of the Certification of the Phase I Unit (UITM) by the Generalitat de Catalunya.
  • Creation, updating and training in Standard Work Procedures to standardize circuits.

Quality requires everyone’s involvement; work together between the different teams and under homogenized processes, always seeking continuous improvement


TEAM

  • Quality
    • Quality Manager: Isabel González, Javier Fonts
    • Quality Technician: Miriam Artigas
  • Sample management
    • Gerard Perez
    • David Vendrell
    • Alma Calahorro
  • Schedulers
    • Laura Castejon
    • Maria Teresa Mendoza
    • Rosa Andujar