Four steps to inspection readiness in CROs
Tegan Oliver 
Date published: Apr 18, 23
Operating in highly regulated industries leaves Contract Research Organisations (CROs) open to inspections to ensure regulations are being met and they are working to a high standard. Ensuring an organisation is inspection ready can often be a daunting task, however with the proper preparation and systems in place CROs can be confident that they are inspection ready at any time and successfully pass an inspection by the FDA or other relevant regulatory body.
What does it mean to be inspection ready as a CRO (Contract Research Orgs)?
As a Contract Research Organisation, being inspection ready means that your documents and records are correct and up to date, and that your facilities are up to standard so that you’re prepared for an inspection at any time. Inspection readiness programs are often put in place to assess teams and business functions across the organisation. These can highlight how successful communication and collaboration is within the CRO, and pick up on any shortcomings within important documentation or the facilities themselves.
Depending on their location and the markets they are working with, CROs should ensure they are compliant with and inspection ready for:
- Good Clinical Practice (GCP)
- Food and Drug Administration (FDA) – US
- European Medicines Agency (EMA) – EU
- International Conference on Harmonization (ICH) – International
- Medicines for Human Use (Clinical Trials) – UK
How can a CRO become inspection ready?
With prior preparation and regular audits, a CRO can become inspection ready by giving attention to the following important factors:
- Regular audits and planning ahead
One of the most reliable ways of ensuring you are inspection ready is to carry out regular audits. This ensures you have insight into any potential issues, and have a consistent bird’s eye view into all activity undertaken. Keeping up to date with audits also ensures you can spot any gaps or issues sooner, so that you can take action to correct them prior to official inspections. - Correctly stored documentation
Although it may seem simple, storing your documents correctly and according to industry standards from the beginning can prevent problems in the future. A robust document review system should be accessible and easy to update while keeping important data secure. Having assurance that all your documentation is stored correctly means you can easily find records that need to be inspected on the day. - Proper training and equipment for employees
Employees are at the heart of any organisation and being involved in clinical trials, it is important that all employees are up to date with required training. Being able to easily evidence the competency of staff members and that they are properly trained on all necessary equipment is crucial for any CRO getting inspection ready. This will include being fluent with policies and procedures, and evidencing these are being carried out correctly. - Industry standard collaboration tools for teams
Providing employees with industry standard collaboration tools is a great way to store and collaborate on your documentation whilst moving towards the goal of inspection readiness. The right solution gives you a secure, central location for CROs to work on important documents with a proper audit trail which regulators can review and inspect.
The benefits of being inspection ready
It may sound like a huge undertaking to be in a position of always being inspection ready, but this is an important consideration for any CRO and can even make the difference between passing or failing an inspection. This is probably the most important outcome of being inspection ready. While some official inspections are scheduled in advance, you may get an unexpected visit from a regulator so you need to be prepared for this at any time.
Being confident that your organisation is proactive and always inspection ready will take away the stress of a planned, or unplanned inspection. The more prepared you are, the smoother the process will be and the less likely it is you’ll encounter any set backs or possible halts to clinical trials. In turn, this ensures that you keep both regulators and stakeholders happy, providing the best results in the ideal timeline.
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