ClinStatDevice LLC is a consultancy, technology and biometrics company creating exceptional Information Technology and Data Analytics solutions to support clinical trials and medical researches. We are providers of high quality data management and statistical analysis services enabling medical device and pharma companies, CROs, government agencies, hospitals and healthcare clinics to advance clinical trials and drug discovery and fulfill their mission of saving and improving lives.

As a company, we aspire to achieving excellence in all we do. From the very beginning we have set highest standards of quality to attain unparalleled results in the field of biotech technology and services.

Hereby, we state that we are committed to directing all our efforts for the advancement of technology, for the timely and high-quality delivery of services to our clients and for the life-improving mission of the health industry.

We do so by:

• Innovating solutions that cater to our clients’ specific needs,
• Being a problem solver,
• Staying watchful of the safety of our products,
• Employing Best Management Practices,
• Embracing agility in our everyday operations,
• Having a professionally run organization,
• Upholding well-founded ethical values.

To be able to achieve this, we have established a Quality Management System (QMS), a management philosophy designed to continuously improve the quality of services/products and customers satisfaction. ClinStatDevice QMS covers the following key aspects:

• QMS products and processes are in place,
• An independent Quality Assurance (QA) unit exists to assure management that the defined QMS is effective,
• Management monitoring and reviews of process performance and/or product quality and of the quality system are conducted,
• Quality and compliance issues are reported to the Top Management through a defined reporting system to ensure that issues that may adversely affect patient safety or the data integrity are dealt with by the appropriate level of management,
• A well-documented system is in place to assess these issues and to identify and implement corrective and preventive actions to avoid a recurrence,
• Risk management principles are effectively integrated into overall Quality processes,
• Effective change management systems are in place for all changes that could affect the safety, quality or effectiveness of a product or process,
• Knowledge is managed to assure lessons are learned from significant internal issues. Good practices, regulatory trends and external inspections are shared within and across business areas as appropriate.

The detailed scope of ClinStatDevice QMS is described in the Company’s Global Policy.

This policy is based on a continual improvement process approach.

ClinStatDevice Senior Management ensures this policy is implemented and maintained through regular review, communication, and improvement activity.