Our clinical research
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 has implemented a Quality Management System, according to the UNE-EN ISO 9001: 2015 regulation 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 to “Design and management of clinical trials in breast cancer and other tumors”.
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 a collective involvement in the achievement of 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 also 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 optimize our ressources and project management.