Опубликовано 11 октября 2017 среда

Why your CRO needs to be ISO 22301 certified?

Disrupted clinical trial data can delay product introduction into the market by several years, or cause monetary investments losses.
The data integrity can be affected by technical incidents, information security breaches, lack of vendor control, legal and financial issues.  
Recognizing the importance of ensuring business continuity, Smooth Drug Development, a leading Contract Research Organization operating in Eastern Europe, has committed to the creation, maintenance and continuous improvement of Business Continuity Management System (BCMS).
The system is based on the ISO 22301 «Societal security – Business continuity management systems – Requirements» standard and covers the company's activities, competitive and regulatory environment, as reflected in the relevant sections of the company's regulations.
Smooth Drug Development team systematically analyzed the entire lifecycle of all business operations and clinical trials activities, identified critical functions and their maximum downtime, and introduced a Business Continuity Plan for each key business process according to the impact that could result from any threats.
This year, Smooth Drug Development decided to go further and to have its BCMS ISO 22301 certified.
ISO 22301 Business Continuity Management certification is another proof of Smooth Drug Development leadership in providing quality and reliable clinical trials services. It demonstrates company's ability to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from any type of disruptive incident for our business and during a clinical trial.
Business continuity management system protects against the likelihood of occurrence of incidents for our business and related to:
  • Study Project Management
  • Information Security
  • Data Management
  • Facilities and Infrastructure
  • Document Maintenance
  • Outsourcing Partners
  • Personnel Availability
  • Legal and Financial aspects
Smooth Drug Development is certified according to ISO 9001:2008 since 2014. Compliance to ISO 9001:2015 and 22301:2012 has been audited and confirmed by European inspection and certification company EUROCERT S.A. in 2017.
The original content can be found here.