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RECIST360 features:

• Ready-to-go: EDC / SDTM data upload, with no re-programming of the tool itself required

• Edit checks (i.e., the ‘Findings’) can be turned on/off, if required

• No double data review of the same data following merging with fresh data (all data review comments are maintained and ‘Findings’ will simply close/open as a result of data changes)

• Findings are easily reviewed and either result in a closure or are followed up via a query (raised in the study EDC system for full ICH/GCP compliance)

 

Examples of best use:

But first, a reminder: The data that contributes to RECIST 1.1 is very special. Whilst not generally labelled as ‘safety data’, it is exactly this: when RECIST 1.1 criteria is applied to collected data, it helps define a patient’s treatment plan in collaboration with their treating physician. With data of this importance, it is imperative checks and balances are in place at ALL stages of the data’s lifecycle. Such in-field treatment plan decisions are derived from scans and measurements, whether manually compiled or automatic in nature (e.g., AI systems with human oversight). And this happens prior to EDC data entry. It’s only when data is entered into EDC - or similar system - that RECIST360 has the potential for sponsor/CRO use. Therefore the RECIST360 tool is NOT a ‘front-end’, clinical, in-field solution, but rather what is known as a ‘backend’ oversight tool. With this in mind, here are some practical uses:

• ensures EDC data entry is correct very soon post-entry

• escalate noticed discrepancies earlier (there’s always the potential sites have made an ‘in-field’ error)

• run the program over mature studies for historical inaccuracies and potential data correction/protocol violation capture prior to lock

• run the program over multiple, locked, studies to assess historical inaccuracies to contribute to future site selection evaluations

• as a sponsor, run the program over multiple studies to assess CRO performance issues and demonstrate CRO oversight occurred

 

Your studies should already have a degree of lesion and response programmed oversight, but an extra layer may help uncover isolated (or systemic!) failings. As mentioned, RECIST360 maintains data review comments and the status of findings between refreshes. However, whilst the technology behind RECIST360 itself is not CFR-21 Part 11 compliant, validation can always be documented on real world/dummy scenarios and, in any event, CFR-21 Part 11 compliant systems must always be consulted and used when resolving data discrepancies for full auditability (chiefly, queries in the EDC application). The use of this tool and the speed and automation it brings to both data review and oversight of existing processes will only help you demonstrate risk-based quality management was well established on your studies.

 

How do clients get started?

RECIST360 is proprietary software designed to deliver value through more efficient oversight, cost savings and earlier identification of potential issues. To protect the integrity of the solution, we provide RECIST360 through a consultancy-led model rather than releasing the underlying tool directly to clients. This enables us to bring the solution to you while ensuring that its creators remain closely involved, providing expert support and reducing the need for extensive client-side training. With this in mind, the following approach may be helpful.

• We suggest trying the online educational facility, because it provides a chance for a demonstration in your own free time, free of charge, with no personal details or data exchanged. From it, not only will you see this tool is a reality, but it can also help avoid unnecessary, costly and time-consuming demonstration meetings (try it here)

• Alternatively – should your raw data or SDTM data differ significantly to that of the online facility – your own dummy data can be sent to info@apples-and-oranges.co.uk and we can return example outputs at our earliest convenience

• After your own and (as you can see) non-pressured and well evidenced evaluation of this solution is made, we suggest you take this discussion further into your team and relevant stakeholders. 

 

In practice this means we can provide documentation of validation against your own data structures (realworld/dummy), will provide continuous .xlsx outputs upon each refresh for documentation and proof of regular oversight, all for filing per your own internal practices. However – and to emphasise - the wider team needs to be aware the coding of the tool itself is never released to a client.

 

Should you still be happy to engage in a meeting to further understand your requirements and iron out other questions and logistics, please do not hesitate to contact us. 

 

With all that explained, we hope you appreciate how simple this is to make your own informed decision as to whether we are a good solution for your need. Finally, availability of the solution will be guided by the level of interest it receives. If you believe RECIST360 may be relevant to others in your network, we would welcome your support in sharing this Linkedin post, commenting, reposting it, or tagging colleagues who may benefit from learning more.