ISO 22301 Certified for Clinical Trials

ISO 22301 Certified Imaging Core Lab

Business Continuity Management System

Quality and timing is critical in conducting clinical trials.  Whether it be for a Phase I, II or III clinical trial or a Class I, II or III medical device trials, business continuity plays a key factor in achieving quality objectives and study timelines.

At Intrinsic Imaging, we have systematically analysed the entire life cycle of the patient timepoint from beginning to end of the trial. We have implemented an ISO Certified Business Continuity Management System and identified potential threats to the clinical trial and evaluated the impacts to business operations those threats might cause.

We then have ensured to provide a framework for building organizational resilience with the capability of an effective response.

At Intrinsic Imaging, we have the most sophisticated and comprehensive quality management system in the industry. Our ISO 22301 Business Continuity Management certification is another example of Intrinsic Imaging’s leadership in providing quality imaging core lab services.

ISO 22301 Certified

Intrinsic Imaging is the only imaging core lab in the world whose Business Continuity Management System is ISO 22301 certified.

Our certification specifically applies to all activities required for a medical imaging core lab to provide services on clinical trials.

Intrinsic Imaging’s ISO 22301 Business Continuity Management System certification demonstrates our ability to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from any type of disruptive incident during a clinical trial.

Protection from Disruptive Incidents

Certified by the British Standards Institute (BSI), Intrinsic Imaging’s business continuity management system protects against the likelihood of occurrence of disruptive incidents occurring on a clinical trial related to;

  • Study Project Manager Continuity
  • Cloud Security
  • Data Integrity
  • Data Transfer
  • Facilities
  • Imaging Site Qualification & Training
  • Image Transfer Delays
  • Infrastructure
  • Informational Security
  • Loss of Patient Time points
  • Outsourcing Partners
  • Personable Identifiable Information
  • Personnel Availability
  • Technology
  • Telecommunications