Context and Scope of QMS, ISMS and PIMS

ClinSoft 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.

ClinSoft is committed to advancing biostatistics and related technologies and the Company’s aspiration is to position itself at the forefront of biotech industry. With this ambition and aiming to to increase reliability and security of systems and information, to improve clients’ and business partners’ confidence and the Company’s credibility and authority, ClinSoft has adopted and got certifications in three international standards:

  • ISO 9001:2015 Quality Management System
  • ISO/IEC 27001:2013 Information Security Management Systems
  • ISO/IEC 27701:2019 Privacy Information Management System

Company has established processes to document, implement and maintain quality and information security management systems and continually improve its effectiveness in accordance with the requirements of the local and international standards. It operates within three management systems that comprise integral parts of the overall management system of the Company:

  • Quality Management System (QMS)
  • Information Security Management System (ISMS)
  • Privacy Information Management System (PIMS)

To meet the requirements, set by the standards and regulations, ClinSoft has set objectives both with respect to quality and information security:

  • Ensure Client satisfaction through timely delivery and quality of services;
  • Ensure employee competence through regular training, development and motivational activities;
  • Provide secure and uninterrupted service for continuous business operations to provide enhanced Client experience.

Ensure secure and uninterrupted service for continuous business operations to provide enhanced client experience