SOPs and Policies
An integrated system of documented and audited SOPs for all our services and activities
We have established a comprehensive Quality Management System, encompassing all our activities. It includes documented SOPs (Standard Operating Procedures) for the development and operation of our SaaS EDC service, for Software Development, Data Management Services and Statistical Analysis Services, as well as for Information Security.
The purpose of our quality management system is to provide our customers with confidence and assurance of the consistent quality of our services, regulatory compliance of their clinical studies and security of their data.
Beyond mere compliance to the ISO 9001 and ISO 27001 standards, our SOPs have been elaborated so as to ensure regulatory compliance and taken into account GCP requirements, EMA and FDA requirements, ICH recommendations as well as industry standards such as the SCDM GDMP for data management.
Our system is regularly audited internally and by external auditors and continuously revised and improved. Our customers are welcome to request more information, such as the list and description of our SOPs, our quality policy and quality manual, or specific SOPs, or arrange documentation based or in-person audits.
Quality Policy
Our quality policy document, which documents the formal commitment of the company at the highest management level and describes our principles and quality objectives is accessible here:
Business Resilience Policy
The purpose of our Business Resilience Policy (BRP) is to outline the technological, management and operational practices, which ensure the resilience of the company in the face of uncontrolled events that threaten to seriously disrupt operations or endanger business continuity for unacceptable time intervals, including external events such as natural and technological disasters, social, political or economic upheavals, and internal events such as major crises and loss of critical infrastructure or key personnel.
The BRP constitutes a more comprehensive and holistic approach than a Business Continuity Plan (BCP) or a Disaster Recovery Plan (DRP), since rather than being responsive and reactive in nature, it focuses on building resilience traits into the design of business processes and of everyday normal operations of the company, thus ensuring preparedness and readiness in the face of major risks.
Environmental Policy
We know that our operations have an impact on the environment. In the context of our responsibility we aim to minimise this impact by establishing, promoting, monitoring and continuously improving our environmental policy.
We are committed to constantly evaluate all our operating procedures aiming to continuously improve their environmental performance in such areas as reduction of either direct or indirect greenhouse gas emissions by our activities, overall energy efficiency, and waste minimisation and recycling;
