ISO 22301: Keeping Imaging Reads, Adjudications and Data Transfers on Schedule Through Disruption

ISO 22301 Requirements

ISO 22301 is the international standard for business continuity management. It requires an organization to identify the activities that matter most to the people who depend on it, to decide how quickly each must be restored after a disruption and what the restoration requires, to put arrangements in place that meet those targets, and to prove through regular exercises that the arrangements work. For an imaging core lab, the standard has five parts:

• Business impact analysis and risk assessment. The core lab identifies the activities that support its services, determines how the harm from losing each one grows over time, sets the time within which each must be restored, identifies the resources each depends on, and assesses the risks that could disrupt them. The analysis is repeated at planned intervals and whenever the lab changes significantly.
• Strategies and solutions. The core lab selects and puts in place the arrangements that protect its priority activities, keep them running during a disruption, and restore them within the required time.
• Plans and procedures. The core lab maintains a response structure with defined teams and named alternates, a means of warning and communicating with the sponsors and sites that depend on it, plans that state when the response begins and who does what, and a documented process for returning to normal operations.
• An exercise program. The core lab tests its plans against realistic scenarios, so that over time every part of the strategy has been exercised, and each exercise ends with a report of results and actions.
• Evaluation. The core lab reviews whether its analysis, strategies and plans remain adequate, and reviews them again after any disruption or exercise.

Two of these parts define the standard. The business impact analysis obliges the core lab to set its recovery targets according to the harm a disruption would cause its sponsors, rather than according to what is convenient to recover, and the exercise program obliges it to show, rather than claim, that recovery is possible.

Why It's Relevant to an Imaging Core Lab

The output of an imaging core lab is time-bound. An eligibility read not returned within the protocol window excludes a subject or forces a site to proceed without central confirmation, an adjudication not completed before a Data Monitoring Committee meeting leaves the committee reviewing incomplete data, and a data transfer that misses a database lock delays an interim analysis or a submission. In each case a disruption at the core lab becomes a protocol deviation or a program delay for the sponsor.

ISO 22301 treats the core lab's reads, adjudications, queries and data transfers as priority activities, assigns each a recovery target based on the sponsor's timelines, and requires the lab to show that it can meet those targets. Intrinsic Imaging's Quality Management page states the result: redundant reading infrastructure, validated disaster recovery procedures and tested continuity plans keep independent reads, adjudications and data transfers on schedule.

Where the Standard Resolves Real Imaging Problems

A Trial That Randomizes on a Central Read

A surgical or device protocol requires a central eligibility read within 24 or 48 hours of screening, and randomization cannot proceed without it. The business impact analysis at the imaging core lab identifies eligibility reading as a priority activity that can tolerate only hours of disruption, identifies the readers, platform and transfer channel it depends on, and sets a recovery target inside the protocol window. The standard then requires arrangements that meet the target, which at Intrinsic Imaging's core lab means a qualified reader pool with alternates, a reading platform with redundant infrastructure, and an alternative transfer path. The protocol window is protected because the analysis assumed that something would fail and planned for it.

A Reading Platform Outage Before Database Lock

The reading platform or imaging archive goes down in the final weeks before a scheduled lock, with reads, adjudications and a data transfer still outstanding. ISO 22301 requires the imaging core lab to have plans that state when the response begins, who acts, what they do and in what order, together with a documented process for restoring normal operations. Intrinsic Imaging's core lab restores the platform from a validated disaster recovery environment within the recovery time set in the impact analysis, with a known limit on how much completed work could be lost, so that the lock proceeds on schedule or with a delay the sponsor was told about in advance and can measure.

A Reader on Whom the Study Depends

A protocol relies on a small number of readers with specialized expertise, and one of them becomes unavailable through illness, departure or a conflict of interest. The standard requires the imaging core lab's response structure to define the competencies each role needs and to name alternates for them, which means cross-trained and protocol-qualified alternates for every reading and adjudication role, so that losing an individual becomes a reassignment rather than a study hold. Intrinsic Imaging's network of more than 750 physicians is the pool from which those alternates are drawn.

What Certification Means for a Sponsor

A sponsor cannot protect its own timelines against a disruption inside an imaging core lab it does not control. Intrinsic Imaging's ISO 22301 certification means that an accredited body has verified that the core lab has analyzed the effect of disruption on every read, adjudication and transfer it performs, has set recovery targets based on the timelines its sponsors depend on, has built the redundancy in readers, infrastructure and transfer channels that those targets require, has written and rehearsed the plans and communications that go with them, and reviews all of this on a schedule and after every event. For a sponsor planning an interim analysis, a Data Monitoring Committee meeting or a submission date around imaging deliverables, that is the basis for confidence that the date will hold.