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Download a sample xlsx output from here.  Try our free online version now from here.

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Background                                                                     See preview video

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Assessment of lesion data is often time-consuming and in many instances is not performed in a methodical fashion despite the emergence of guidance such as RECIST 1.1.  These 'rules' whilst providing a common framework across studies, still leaves the review of the lesion data itself performed inefficiently. EDC platforms often have a limited number of edit checks and any programmed listings are often too complex for the end user to understand. This often ends up with medical review at the critical end of a study which is often performed with the use of flat files laid out incoherently.

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RECIST360 has been programmed to enable multi-disciplinary review of the lesion data in a cyclical fashion. Programmed checks (study specific, RECIST 1.1-rules and logical) enable the reviewer to quickly establish where the issues exist via visual graphing methods or via text-based 'findings'.

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RECIST360 features: 

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• EDC / SDTM data upload with no programming requirement

• Study-specific rules can be integrated at study start

• Edit checks can be turned on/off if required

• Preventing the need for double data review of the same data from different timepoints (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)

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Functionality

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​How do clients get started?                                                                                      SEE MORE HERE

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• Clients will have access to a FREE specification document (contact us) which details the required raw data extracts & formats that will feed into the tool.

• The per-specification raw data extracts can be re-run as required (e.g. within the EDC reporting engine or SDTM delivery)

• The specifications document automatically verifies correctness of the raw data extracts and provides clear feedback as to any data issues (e.g. dates not formatted as expected).

• By utilising the specifications tool, clients are under no obligation to proceed to adopt the tool, there is no transfer of clinical data to A&O and no cost to the end client.

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Once extracts are correct, the client can then choose to purchase the full tool on an annual and renewable basis​

 

How and when does this tool get refreshed?                                                         SEE MORE HERE

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• Due to some of the critical checks included in the tool, we recommended the tools is refreshed weekly, taking a pro-active approach to risk-based monitoring, in addition to remaining inspection-ready at all times

• The client will extract the same raw reports, but on fresh data

• This data is uploaded into the tool via a file upload facility

• The tool runs its own ‘proc compare’ program to establish changed and new data

• => No double-data review!

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No exchange or transfer of client data

Minimal cost or risk

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See below video for a better understanding of how the tool can help you! We welcome your comments which you can leave at the bottom of this page. A more in depth video version can be found here.

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