An integrated system of documented and audited SOPs for all our services and activities
We have established a comprehensive ISO 9001 / ISO 27001 certified Quality and Information Security 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. The purpose of our quality and information security 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.
Our Quality Policy, which documents the formal commitment of the company at the highest management level and describes our principles and quality objectives.
For any quality related issue, including customer complaints, you may contact directly our QA Manager at firstname.lastname@example.org
Information Security Policy
Our Information Security Policy documents the strategic commitment of the company, to implement all the necessary technical and organisational measures necessary to achieve and maintain the high level of information security required for our business environment. It also provides our customers, users and all interested parties an overview of the way our ISO 27001 certified information security system is organised and managed.
Information Security Policy (digitally signed PDF document)
For any information security related issue you may contact directly our Information Security Officer at email@example.com