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.
This unit comprises quality and transversal support teams including sample managers and schedulers. We perform various tasks related to clinical trials, develop and implement standard processes, and ensure quality excellence.
Optimal quality assurance is a critical element of clinical trials and the enhancement of study procedures. All activities comply with Good Clinical Practice (GCP) guidelines and current regulatory requirements, with the rights, safety and well-being of patients remaining the paramount priority.
- Provide cross-support and perform clinical trial activities including scheduling, the management of samples and quality assurance, and the standardization of processes.
- Administrative management of clinical visits, follow-up and treatment of patients participating in clinical trials at VHIO.
- Standardize and optimize processes and circuits to reduce patient waiting times and provide the best possible service.
- Establish circuits for the optimal management and processing of clinical trial samples.
- Collaborate closely with all teams involved in clinical trials at VHIO to identify and resolve any intances of non-conformity.
- Conduct periodic quality control and internal audits of documentation, site inspections, circuits and procedures.
- Obtain renewed certification from the Government of Catalonia of VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch.
- Organization of courses and training sessions in-house including: Good Clinical Practice (GCP), revision of electrocardiogram (ECG), cardiopulmonary resuscitation (CPR).
- Conduct regular training sessions to review and further enhance quality.
- Develop and update Standard Operating Procedures (SOPs) to standardize circuits and provide all necessary trainings.
- Clinical trials in oncology and hematology.
- In 2023, we have collaborated in more than 700 active clinical trials, and have successfully passed 26 external audits, 8 internal audits, 2 U.S. Food and Drug Administration (FDA) inspections, and 1 inspection by the Government of Catalonia for the recertification of VHIO’s VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch.
- Continued improvement of circuits, monitoring to identify and resolve any incidents, and the standardization and optimization of processes.
- We have also participated in the internal training of staff involved in clinical trials.
- VHIO’s Moodle learning platform for internal trainings and the SOPs Reading Log.
