ACTRIS – setting the scene

Before I can extend on what ACTRIS can mean/do for you and your team, I need to set the scene.

You have a team in place, that consists of several in-house and several remote members, with one Project Manager (the lead). This/your team works or will work on a Clinical Trial/Study, in a regulated, GxP environment;

  • Using a Risk Based Monitoring approach, based on a Risk Assessment
  • Implementing risk proportionate approaches in general and to Project Management and Safety Management

The basic assumption is that the team want to diminish use of e-mails and other reporting, and instead will mainly use ACTRIS to work on/with potential risks and issues run into. Use of ACTRIS is especially beneficial to teams adapting ‘Distributed Work‘, in different time zones, depending on their availability. Each team member will be informed on issues/potential risks in real time and can contribute towards their resolution etc.

SIC will offer you ACTRIS as Software-as-a-Service, based on a Service Level Agreement. ACTRIS runs from basically any browser, and from an App, on Atlassian’s Jira Cloud, to which SIC will have the license. SIC will be the administrator of your site/instance. Atlassian will be the data processor as per their Data Processing Addendum, with Terms of Service and Privacy Policy in effect.

-> Please page through the next pages to review what ACTRIS can mean/do for you/your team.

See next page.