With a traslational-basis, our trials are grouped under three programs:
Phase I, II and III classical trials, proof-of-concept. Involving quite a large period of time, they give us information on a drug’s efficacy.
Trials with no drug-intervention. Samples collection + correlative analysis of tumors and liquid biopsies. Looking for clinically-predictive biomarkers and mechanisms of resistance.
Very informative trials at a biological level. They take advantage of the period between the diagnosis and surgery to test new therapeutic strategies.
Quality Management System
SOLTI-DBMS is an online platform designed to provide SOLTI members and the scientific community with access to genomic and clinical data from SOLTI-sponsored studies.
The goal is to make genomic and clinical data more accessible by translating into more research projects or scientific questions that will help address clinical needs and increase global knowledge about cancer biology.
QUALITY MANAGEMENT SYSTEM
SOLTI as implemented a Quality Management System, according to UNE-EN ISO 9001: 2015 since 2017 with certificate number: ER-0082/2017 / A and with international IQNet certification, of great international recognition, by AENOR, with a scope of application a “Design and management of clinical trials in breast cancer and other tumors.”
For this, a Quality Policy has been defined based on the following principles:
- Quality as a strategic element in the organization.
- Commitment to legal and internal compliance with our quality system.
- Satisfaction of our clients, in order to satisfy their expectations.
- Commitment to the continuous improvement process.
- Promote the training and awareness of employees on quality issues.
- Define quality objectives and review them periodically.
- Work to create a good work environment and collective involvement in achieving the objectives defined from the strategic lines established by the company.
This policy is communicated and understood by all the organization’s personnel, as well as external parties.
We have established a series of improvements that have meant an important advance in management and quality issues, such as:
- Work by processes, which has allowed us an optimization in the different stages of these.
- Electronic management of the documents of its Quality System, speeding up the knowledge and compliance with the applicable legislation.
- Rigorous quality control in the main activities and archive of clinical trials.
- Annual planning of audits, both internal and external.
- Systematic implementation of risk assessment both at the global level of the company and at the project level.
All of this has contributed significantly to optimization both from the point of view of resources and project management.