Smooth Drug Development announced gaining the internationally renowned ISO 9001:2008 certification. This important acknowledgment further strengthens the company's position within Russian, Eastern European, and international markets.
Dmitry Morozovsky, MD, EMBA, CEO of Smooth Drug Development, says:
"For Smooth Drug Development's team, the fact that the Company has been awarded ISO 9001:2008 certification attests to its quality and high standards, which our specialists, our processes, and our operations have been adhering to. Especially now that the pharmaceutical industry faces the ever-rising demand for high quality of drug development and best-in-class clinical operations, by becoming the first ISO 9001:2008-certified CRO in Russia, Smooth Drug Development confirms its dedication to keeping abreast of requirements of the medical community."
ISO 9001 sets requirements for the quality management system within an organization. The certificate acknowledges and validates high quality standards that the company is committed to at all organisational levels, within its activities and operations, structure and organisation, human resource management, etc.
The ISO 9001:2008 certificate received by Smooth Drug Development covers the following scope of activities and processes: conduct of clinical trials for registration of pharmaceuticals for human use: planning, project management, vendor selection and management, medical writing and expertise of documents, conduct of training programs, clinical and medical monitoring, pharmacovigilance, data management, biomedical statistics, quality assurance and quality control.
Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) are essential parts of the clinical research quality system. However, how these processes are set up, managed, and their effectiveness and efficiency are not fully covered by SOPs and GCP.
Along with the Quality Management System and Business Continuity Plan designed by Smooth Drug Development to encompass all aspects of operations, effecting the requirements of ISO 9001:2008 certification became the next progressive step integral to the company's quality.
Source : http://finance.yahoo.com/