Quality Assurance
Our strength stems from our commitment to quality, which is applied to all our activities. Given the high standards required by our clients and the Health Authorities and in order to preserve patients' interests, it is essential to ensure the quality, accuracy, security and confidentiality of the data and results we process.
The quality assurance system implemented by 4Clinics is a guarantee for:
- Conformity with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Good Clinical Practices (GCP)
- Conformity with international standards (FDA, EMEA)
- High quality level of final deliverables
- Timeline management
- Validation of data management systems
- Security of data and information systems
- Confidentiality of information
- Availability of documentation on our procedures
- High level of professional ethics
- Accurate risk management and guarantee of follow-up
The Quality Assurance system of 4Clinics is based on Policies and Standard Operating Procedures (SOPs). The monitoring of the Quality Assurance system by the top management of our company is a reflection of our commitment to ensure quality throughout our activities.
The Policies, which are established by the upper management and are applicable to all of our areas of activity, define the strategy and the objectives related to quality.
The SOPs are established by the manager of each department, according to its area of activity (executive, security, human resources and data systems). The SOPs specify the procedures to be followed for each function within a particular area of activity and also how to report these activities.
The Quality Assurance system ensures that all 4Clinics'members are aware of and are trained in quality aspects. Thus, at 4Clinics, quality is everyone's business.
Together with the high level of competence of its staff members, 4Clinics counts on this quality approach to distinguish itself in the market.
Our Quality Assurance system facilitates the qualification visits and the quality audits for our clients.
