CLI for OpenCDISC Enterprise version

CLI for OpenCDISC Enterprise version

Hi Dmitry,

There are a few questions included in here, let me describe a bit.  OpenCDISC Enteprise has only been installed locally at FDA and for PMDA.  After evaluating it, our other clients have all gone with having P21 host it for them.  But to answer the question - yes, OpenCDISC Enterprise can be deployed locally.  

Integration with OpenCDISC Enterprise is handled via REST APIs.  Many people want to connect their Metadata repositories and SDD installations with it.  

I talk to a lot of people using Community and I've seen some have interesting installations that provide some centralized management of OpenCDISC Community that, when you then look at Enterprise functionality,  no longer become needed if you go that route since it addresses that challenge and more differently.  

So, depending on your use case, can send an email to me at support@pinnacle21.net and I can speak with you more about how to achieve your goals.

Hi Travis, thank you for the

Hi Travis, thank you for the detailed explanation. I'm afraid it is unlikely that I can persuade my company to change current local approach to the web-service way. I'm sure it worth it, because you guys are doing a great job.

If it is a web service, the disadvantage, comparing with a local approach, can be in validation of large datasets. With a local OpenCDISC I can simply run a check and validate a dataset right after I created a it. There are many white papers explaining how to do it directly from SAS(or whatever). But if I have to upload it to a web-server first, it will tremendously increase validation time, given that datasets larger than 100mb are not so rare. I guess you can compress them before upload, still it also takes time.

Upload time

Hi Dmitry.    OpenCDISC Validator requires a zip file of your SDTM datasets, whether it be 1 or more.   SAS xpt files compress very nicely.   With an upload rate of 8 Mbps, a 750 MB file will upload in 12.5 minutes.  That same file contained about 25 GB of data.   So if you wanted to integrate and automatically validate in Enterprise using Web api, this is still feasible.   Most times the upload will only take seconds to a few minutes.

Enterprise uses the Aspera secure technology for uploads.  these benchmarks are accurate.   The biggest limitation is your company's upload rate.

http://asperasoft.com/resources/benchmarks/#transfertimes-630

Hi Michael,…

Hi Michael,

Thank you for the examples and details on the Enterprise version. Unquestionably there are benefits of a cloud version over a local CLI version. Still one of the main concerns for CROs is that they cannot upload client's data anywhere and usually do not trust clouds they do not have control over (although I know that most of the big pharma companies are using Pinnacle 21 cloud). There are other standards and rules which are better managed locally, because all of the tools and processes are already in place, for example blinding or access control.

My guess is that for companies which are using CRO services, validation of a dataset requires rather limited number of iterations. You get the data, upload it to Pinnacle 21 cloud and validate it. Nice and easy, plus you have good tools to analyze and control it. While for companies which are developing datasets, it is required to validate them more frequently. I personally prefer to validate a dataset after each rerun and waiting for several minutes for it to be uploaded to a server and then download the results back looks to me unnecessary spent time, given that a local CLI version can do it much faster.

I cannot speak for my company, but I believe that there is a demand for a CLI tool, which will allow to validate data on a local machine, exactly the same way, the current Community version CLI does it and satisfies the regulatory requirements. I just wish there was an Enterprise CLI version, which will be better supported and have ability to validated standalone define.xml.

Thank you.