Headed by Gemma Sala, VHIO’s Quality and Processes Unit was established in 2020, in order 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 management and schedulers At VHIO we run numerous tasks related to clinical trials. It is therefore imperative that all these activities – and the personnel who perform them- are carried out by assuring optimal quality and excellence, and that the processes governing them are both homogeneous and the very best.
Quality is key to correctly performing clinical trials. Guaranteeing that all the current regulations of these studies be 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 improvements implemented.
- 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 and procedures.
- 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.