nav[aria-label="Primary Navigation"] { padding: 0; & ul { list-style: none; width: 100%; display: flex; flex-direction: row; justify-content: start; align-items: start; gap: 30px; padding: 0; & li { margin: 0; } & ul li { list-style: none; } } }

Built-in Data Conversion and Mapping tool for JMP Clinical

Chris_Kirchberg

What inspired this Wish List Request?

Many JMP Clinical (and potential JMP Clinical) Customers need to extract their data from Databases Called EDCs (Electronic Data Capture) to use for reporting/analysis. In order to use JMP Clinical, they need to format the data so JMP Clinical and read the data and run the built-in reports that take advantage of CDISC standards (SDTM/ADaM).

Please describe the new or improved feature or solution you would like to see.

Currently Don McCormack made an Add-in to help Map customers column names n their .sas7bdata, .xls/.xlsx, .csv, .txt, or .jmp files to variable names from SDTM and save them with proper file names and file extension (.sas7bdat) for the different data sets used by JMP Clinical.

This is a separate tool and not integrated into JMP Clinical. It also needs to allow for other data manipulation like stacking and changing data formats for timing variable as well as other variables that conform to CDISC standards

What would the value be to you and/or other users if this new feature is provided?

Current and potential customers need to get their data and reformat it in near real time (daily at best, usually weekly) and then use within JMP Clinical. Many customers struggle with having the proper resources (programmers) to make these scripts/programs to get their data ready and rely on CROs to do it for them. That can take a month or longer depending on their contract with the CRO.

Even larger Pharmaceutical companies who engage in early stage clinical trials will rely on CROs to get their data ready and only have access to the text files exported from the EDC and then get stuck as to how to visualize/analyze in Excel.

This mapping/conversion tool integrated into JMP Clinical will expedite the review of their data and reduce the dependencies on CROs to get their data ready to be used by JMP Clinical (even if it is still a little dirty/not perfect.).

It is also a good selling point for smaller/mid-size companies who do not have the resources to write the programs themselves.

Is this an external customer request?

Almost all JMP Clinical users. Recent activity in Regeneron and BMS as potential customers

Is there a competitive software package that has this feature or solution that we should be aware of?

No. People write programs in SAS or other language to do the mapping or they map within tools like Spotfire (which still required coding of some sort)

Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?

It can. Please reach out Regeneron and BMS AE to ask more details/status for these customers. Also ask other AEs as to which current customers might better adopt or might have a risk of renewal. It has a greater impact on prospective customers as small and medium sized Pharma's.

Status: In Review

Comments

alisa_h_lowery

In my experience working with JMP Clinical deals (e.g. Precision Biosciences Carolinas 2021), mapping was a huge deal for them. They hired an intern to help with that. We were fortunate that the timing worked out & they got some assistance in addition to the mapping tool. Data formatting always seems to be a hurdle for customers in using Clinical.

Byron_JMP

The most common comment we hear when pitching JMPC is, "We only put the data into CDISC at the end". Followed by "How do we get our data from our EDC* to CDISC". Having an application to make this easy would be a huge selling point. Don McCormack's add-in helps, but a more full featured application with table pre-processing and the ability to handle the SAS Names and Labels should be included. Something like a workflow builder and table mapper for Clinical or a Clinical query builder.

*Electronic Data Capture is a software used for collecting clinical trial data. An electronic case report form, or eCRF, is a digital (usually web-based) questionnaire for collecting data about a study participant. There are many vendors and configurations.

nick_shelton

A large portion of JMP-C users I've assisted (data managers) rely on other teams & statisticians to develop the CDISC datasets they require to use JMP-C. This improvement will make JMP-C more accessible to those users and allow for quicker reporting of clinical trial details.

SamGardner

This is definitely on the roadmap. Step 1 would be to update the current Mapping add-in to to ensure it works well. Step 2 is to include the data mapping tool into the product itself.

Alex_Xu

This is certainly beneficial for Chinese JMPC users where CDISC is not a mandatory regulatory standard.

Some of my JMPC users and I have tried the previous addin, whose main function is column name mapping of non-CDISC datasets to CDISC datasets, and therefore requires users with some knowledge of SDTM/ADaM specifications, usually Data Management and Statistical Programmers. However, since most people who read Clinical reports, such as medical and pharmacovigilance departments, are not knowledgeable about CDISC standard, the population that converts the data and uses the reports remains different. It would be nice if JMPC's Conversion and Mapping New Feature could be navigated by these same people who read the reports on their own.

In addition, in terms of personal sales experience.
- No user will use all Clinical's reports.
- Clinical's reports also do not use the full variable from the full SDTM and ADaM datasets, but a subset of them, a light version.

Therefore, if we had a positive, concise and clear "CDISC Variable Index" for each Clinical report, it might help guide and simplify the data conversion efforts of JMPC users.

In the previous JMPC 8.x, despite similar considerations.
- "Check Variable Requirements and Usage" function: independent of the individual sub-reports before they are started, not aggregated.
- "Data Management > Variable Report" function: based on verification of loaded data, not particularly convenient for the user to know which variables they should have in order to generate the report they needs.

Jessica_Wang520

In China, all my JMPC users will have a good impression of Clinical reports, but the major problem is the "data issues". For clinical trials, they usually don't convert EDC "raw data" into "CDISC data" due to limited internal resources and budget for CROs. We look forward to having this data mapping tool to benefit our medical or PV users in cooking data and then they can use JMPC in phase 1 and phase 2 easily.

Sarah-Sylvestre

SamGardner

@Chris_Kirchberg this is definitely something we are consider for the v18 development cycle. Thanks for the detailed and clear wish list item!

SamGardner

We are planning on adding a new Clinical Data Mapping tool in v19.