Publisher: a new component of the MainEDC™ system

Data Management 365 continues constant development and improvement of the MainEDC™ system, so we happily announce the start of the trial period for the new System component – Publisher! It automates the study-specific configuration transfer from a testing environment to production and allows a very short time for the transfer. Publisher has been validated by DM 365 and offers many useful options.

After the end of the trial period, the new component will be activated for clients so that they are able to transfer the study-specific configuration between their environments on their own, without reaching out to DM 365 Helpdesk and waiting. Please note that activation and use of this option will be free of charge and can occur once the training and validation approach is agreed between your team and your dedicated DM 365 Project Manager (expectedly, no later than in April, 2023).

The trial period has its peculiarities, which force us to draw your attention to the following:

Currently, all transfers are controlled manually, to ensure maximal safety of our clients’ data. In the debugging mode, it may take extra time (temporarily). We thank you for your patience and understanding and we certainly do our best to shorten the transfer time as much as possible. It would be very helpful if you could request a project transfer 2-3 days in advance, so that we can plan and execute it to your full satisfaction.
To perform the requested project configuration transfer, DM 365 Helpdesk will utilize service roles with certain access permissions to your testing and production environments and to the specific trials. Current procedure assumes that we ask for such permissions case by case. To expedite the transfer process, we now seek your general permission to grant the needed access for service roles by default. We assure you that the access is used solely with the purpose of service delivery, no data will be affected. Also, all the activities will be logged in the System audit trail. Once the service roles are no longer needed, they will be deactivated, the Helpdesk access to your environments and trials will be revoked.
The new tool includes an automatic creation of a downloadable Release Note that captures all the details of the transfer performed (unlike the old form that was developed manually). For every new transfer within the Publisher trial period, we will share the downloaded .pdf file instead of the form PM-FRM-002-04. We welcome your suggestions on how to modify this file appearance and content. However, if you still prefer the PM-FRM-002-04 form for any reason, please let us know.

There is one more request for you to consider please.

DM 365 Helpdesk often receives claims that clinical sites (Investigators, Pharmacists) face difficulties while accessing or working on the *.investigator.site class websites. For troubleshooting, the Helpdesk team primarily use their accounts associated with the *.mainedc.com (CRO class) websites. The service algorithm look like this:

Try and simulate the error from the CRO side
Try and simulate the error on the DM 365 internal testing environments
Try and simulate the error on the client’s testing environment
Seek client’s permission to create a temporary user account in the client’s production environment to run and watch the live scenario (it is worth mentioning here that we have never seen a rejection from any client).

Typically, Helpdesk manages to solve the issue at the first steps of the algorithm. However, when it goes as far as to the last step, the resolution becomes quite time-consuming. Thus, same as at point 2 above, we kindly ask your general permission to create the needed accounts on the production environment (clearly recognizable like e.g., Helpdesk Investigator or Helpdesk Pharmacist) without reaching out to you case-by-case and solely for the purpose of troubleshooting, in the specific studies and sites. No data will be entered/edited/deleted. Once the problem is solved, we will revoke the Helpdesk user access by establishing the flag EDC Access = No. Again, same as at point 2 above, please note that all the activities will be logged in the System audit trail.

We realize that, unlike pt. 2, this pt.4 covers more sensitive matters but, still, we seek your approval aiming to make our service more efficient and convenient for you, eventually.

Thank you for helping us become better and better!