Commitment to Quality
Quality assurance in healthcare is rather a necessity than just a qualification. Thus, corner-stone of our mission is to provide high-quality services to our clients, aiming to meet their needs and most demanding expectations.
How we achieve it
To have this mission accomplished, our company developed a quality culture, embedded into all aspects of business operations, from the implementation and maintenance of a Quality Management System (QMS), the continuous monitoring of legislation and regulatory updates, to the compliance with business ethics and the development of practices ensuring financial sustainability and social responsibility.
But our commitment to quality goes beyond the delivery of high-quality services. It also focuses on meeting our endeavors for continuous improvement of our systems, processes, operating procedures and standards. This is our Quality Assurance (QA) team's responsibility: to monitor our Quality Management System's effectiveness and, through regular quality controls and audits, identify any process or practice that could keep us away from excellence!
How can we prove our committment?
As a token of our commitment to quality, we have been awarded with ISO 9001:2015 certification, which extends to all divisions and functions of the company and ensures that all company's activities are carried out to the highest technical, scientific and professional standards in full adherence to:
- Local, national and international legislation
- ICH Guidelines and Principles
- Ethical, legal and regulatory standards
- Standard Operating Procedures
- ISO 9001:2015 Requirement
Quality Policy
CORONIS RESEARCH S.A. is primarily engaged in providing services for clinical study design and conduct to international and local pharmaceutical, biotechnology and medical device industries, as well as pharmacovigilance, clinical data management and statistical analysis, medical writing, regulatory affairs, patient support programs, training, consulting services in healthcare sector and medical information management. The Company’s management has developed its Quality Policy based on the provision of high quality services, using effective methods of implementing the obligations undertaken towards its clients in order to be highly competitive.
CORONIS Research S.A. through its Quality Policy is committed to:
- Provide high quality services
- Comply with all legislative and regulatory requirements and obligations
- Complete the projects on schedule and meet its client’s requirements
- Develop mutual trust and cooperation with its suppliers
- Effectively address and satisfy any existing and projected needs of education, training and expertise of employees in the company
- The availability of necessary resources for maintaining and improving the effectiveness of the Quality System of the company
- Determine and review the achievement of the quality objectives at regular intervals
The tool through which the company implements, monitors and adjusts, when necessary, the quality policy, is its Quality Management System.
The validity and recognition of quality management and safety systems is achieved through their certification by an independent Certification Body in accordance with international current ISO 9001 standards.
In order to implement the Quality Policy, CORONIS Research SA considers that the active participation of employees in the compliance, development and documentation of all procedures under the Quality System, is necessary. After all, the employees in the company contribute to the effective implementation of quality management system and its improvement, while its compliance is binding for the company.
ISO Quality Certification
Our company has been certified to the EN ISO 9001 International Quality Standard since 2004, representing the Company's never-ending commitment to continuous improvement and provision of high-quality services and solutions.
The present certificate states that the Quality Management System of the Company (including all processes) meets the requirements of the new International Standard ISO 9001:2015 with the following scope:
Provision of Services for Clinical Study Design and Conduct to International and local Pharmaceutical, Biotechnology and Medical Device Industries, as well as Pharmacovigilance, Clinical Data Management and Statistical Analysis, Medical Writing, Regulatory Affairs, Patient Support Programs, Training, Consulting Services in Healthcare Sector and Medical Information Management.
