SOPs
The Standard Operating Procedures (SOPs) implemented by 4Clinics ensure that the activities will be performed:
- According to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Good Clinical Practices (GCP)
- According to the international standards (FDA, EMEA)
- Following pre-established and well-known procedures
- With efficient management of the delays
- With documentation on all our activities at each step
- With a high level of security and confidentiality
- By staff members highly competent and trained in quality requirements.
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 SOPs of 4Clinics cover the following aspects:
- Regular update of the CV and training record of each of our staff members.
- Physical security, facility access and database access
- Follow-up of the activities and risk management
- Documentation on database installation and database update
- Database validation
The SOPs are adapted to the different domains of activity of 4Clinics, with specific and detailed procedures for:
- Data Management
- Biostatistics
- SAS programming
- Scientific Writing
- Safety
- Clinical Trial Management
The 4Clinics' SOPs can be accessed by our clients for the preparation of their qualification visit or audit.
We are also flexible on whether to apply 4Clinics' SOPs or those of our clients, depending on the characteristics of the activities or project. Our staff members can therefore be trained in the client's SOPs, leading to a consistent collaboration with the client's teams. In this case, a document related to the procedures to be followed by our staff members is added to the project and continuously updated.
