ClinStatDevice LLC is specialized in providing end-to-end clinical study support, such as consulting, clinical research services, bioinformatics, biostatistics, and other related healthcare software development and related technology services to pharmaceutical and biotechnology companies worldwide. The Company services cover many therapeutic areas and different phases of clinical development, ranging from building clinical data management, monitoring and analytics software platforms to comprehensive clinical trial consulting and biometrics.
ClinStatDevice LLC and ClinSoft LLC work under the same QMS in accordance to Unified Quality Management Systems Agreement. Company has established processes to document, implement and maintain integrated QMS, ISMS and PIMS and continually improve its effectiveness in accordance with the requirements of the local and international standards. The implemented QMS, ISMS and PIMS of the Company are integral parts of the overall management system of the Company. Risk management principles are effectively integrated into overall Quality processes, effective change management systems are in place.
In accordance with established Global Policy, the development and distribution of Company products and services are conducted in compliance with relevant International Codes, Standards and GxP regulations. Local regulatory requirements, as well as the requirements of the countries to which products and services are to be supplied, should be considered and satisfied. Management of Company operational units are to: • Provide the strategic direction for guiding the quality environment improvement; • Ensure the availability of necessary resources; • Ensure that everyone understands the importance of work quality and his/her responsibilities; • Implement the QMS based on the applicable regulations and Company standards; • Regularly review and continually improve the QMS and its processes; • Monitor Clients’ and Suppliers’ requirements for facilitating mutually beneficial partnerships; • Define which parts of this Policy, as described in the following sections, are applicable in the area of respetive operational units, and ensure that those parts are implemented and maintained properly; • Ensure regular reviews of compliance with this Policy.
The Company Management ensures Client requirements are identified and are met with the aim of enhancing Client satisfaction
