SimpleTrials Hosting in the EU / EEA

Existing SimpleTrials Clients may request to move to the Frankfurt hosting location.

OPT IN for EU Hosting CLOSED on Friday 30 Apr 2021. This page is still available for informational purposes.

Based on popular demand, in conjunction with our support for GDPR, we are delighted to be expanding SimpleTrials to offer hosting in Frankfurt, Germany.  Existing clients must opt in by Friday, 30 Apr 2021, to be moved from the current US hosting location. The move will occur on Wednesday 05 May 2021 (evening, Pacific time).

This is a one-time opportunity to move to your SimpleTrials workspace (all studies, all data) to the new Frankfurt location.  To offset the effort associated with this move, there are additional fees: $999 one time fee for the move; $349 per month after the move (discounted 20% for annual subscribers).

See the FAQ below for additional details.


FAQ

last updated on 25 Mar 2021

Can TBFS provide details about the process to move client workspaces from the current US hosting center to Frankfurt, Germany?

Yes - SimpleTrials is provided as a multi-tenant offering in the AWS US-East1 data center. This means that all client workspaces share one server environment and database, and client data is partitioned logically. In advance of the planned EU move, TBFS will work with our established Infrastructure-as-a-Provider (Amazon Web Services, AWS) and Platform-as-a-Service-Provider (EngineYard), to install and qualify the alternate server environment in the Frankfurt data center. On the go-live day for the relocation, our qualified and test backup-and-restore procedure will be used to relocate clients who have opted-in to the Frankfurt hosting location.  Installation qualification and acceptance testing will be performed by the TBFS team to ensure the EU server is qualified for use. The workspaces that are relocated will be deleted from the OLD US hosting location (and vice versa for the US workspaces to remain in the US location). Clients with data hosting in the EU will have a NEW URL to access their workspace while clients that remain in the US hosting environment will continue to use app.simpletrials.com to access their workspace.


If I have some studies that are conducted in the EU and others in the US, is it possible to move only the EU studies to the EU data hosting location?

No - clients need to choose the singular environment (US or EU) that best fits their needs for ALL studies (current and future) in their workspace environment. 


Will we have the opportunity to move our hosting location at a future date?

No - As described earlier, the process that will be utilized to move a client workspace to the EU hosting environment involves a backup & restore of the entire multi-tenant environment that includes all current SimpleTrials clients. It is not possible to repeat this process for the purpose of moving clients; however, it will be possible in the future to subscribe to the desired environment for the workspace. As a workaround, clients could manage two subscriptions to SimpleTrials if they need to manage multiple hosting environments. Because this is not ideal for many reasons, we recommend making the move to the EU hosting location now if a client expects to manage data for European citizens (sites, teams, patients) through the SimpleTrials application. Also note that TBFS will not be able to support a move “back” to the US hosting environment.


Will the server timezone change, or will my team notice any performance delays if our team is not located in the EU near the data center?

SimpleTrials uses UTC for all clients, with user-specific time zones for display of timestamps.  Therefore data records will not be impacted.  TBFS does not anticipate any noticeable performance issues for accessing SimpleTrials from the EU hosting environment.  Users in closer proximity to Frankfurt (than the US) may see a performance improvement.


Can you clarify if there will be any changes to user support provided if we move to the EU hosting location?

There are no changes to user support. The Master Service Agreement (MSA) specifies that email and web support (English language) are provided between 8 am - 5pm Pacific time (which includes the shift from PST to PDT for daylight savings). The SimpleTrials support team endeavors to provide support during extended hours as well (early morning and evening).


Will TBFS generate any documentation to support the data center move?

The effort by TBFS to support our client’s requests to offer EU hosting will be extensive. Internal efforts will include test planning and acceptance testing, performing installation qualification (IQ), conducting disaster recovery (DR) testing and updating associated configuration documentation. This documentation will be available to review via online audit post launch.  Please see the "Fact Sheet - Validation" in the SimpleTrials Compliance Portal for more information on the audit process and fees.


Can you provide some background regarding the costs associated?

TBFS is charging a one-time relocation fee of $999 and a recurring monthly fee of $349/month (20% discount for annual plans) after the client environment has been moved. The one-time relocation fee covers the efforts associated to communicate, schedule, plan, test, execute and verify the move on 05 May 2021. The $349/month recurring fee helps to offset the additional application server costs, additional test servers for the EU environment, compliance and qualification of the new environment, expanded support costs for multiple multi-tenant environments and the associated ongoing maintenance costs associated with maintaining multiple instances of SimpleTrials as a validated CTMS offering.


How is disaster recovery supported for the Frankfurt hosting location?

SimpleTrials has a documented and tested process for backups and disaster recovery.  Nightly, encrypted backups will be generated. A disaster recovery server (warm backup server) will be deployed, setup and qualified at an alternate EU-based data center (Ireland).


Can you provide any additional details about how this move will impact our users?

  • New URL to login to SimpleTrials
    Users whose workspace is moved to the EU should expect to go to an updated URL to access their SimpleTrials workspace (e.g. instead of app.simpletrials.com, they will go to eu.simpletrials.com to reach the login page). From there, the SimpleTrials application will behave exactly the same in terms of functionality available, support materials and help ticket support from the TBFS team. Finally, Admin users may notice that TBFS has enabled the two fees in the Administration/Subscriptions and Settings page. Because these fees are required once a client has opted-in to the hosting environment move, Admin users will be unable to manage them further.

  • Email addresses for "eTMF Email In" will change
    Clients will need to re-copy the email address from the SimpleTrials Site Details view, as the hostname in the email address will change to reflect the “eu” location.

  • Calendar sharing URLs will change
    Clients will need to re-copy the URL from the Study Profile Section 1, as the hostname in the URL will change to reflect the “eu” location.


The communication from TBFS mentions support for GDPR. Can you clarify further?

The General Data Protection Regulation (GDPR) went into effect in May 2018 to provide enforceable requirements to ensure that appropriate technical and procedural measures are in place for the processing of personal data from data subjects in the European Economic Area (EEA) outside of the EEA. Because SimpleTrials clients have personal data for EEA citizens (e.g. site members, team members and subjects) processed through SimpleTrials, it is beneficial to have the CTMS data hosting environment located within the EU.