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.

About S.I.C.

Smeets Independent Consultant - SIC, is the full name of my/Edgar's company, established in 2003. I am a sole trader, in the Netherlands known as 'ZZP'. The company is registered with the Chamber of Commerce (KvK) number: 39.08.30.34, and is VAT registered. I partner with (bio)pharmaceutical companies, start-ups, Institutions, investigators, or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed using efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up. I have a few SOPs in place myself to cover the topics 'Physical and Digital Security', and 'GDPR; Preventive and Corrective Measures', in my home office. You are kindly invited to explore this website, and please DO contact me with any questions.

Services offered

In general I offer a rather straightforward, efficient set of services when setting up your research project/trial, and represent my client when following through during the execution of the trial(s). I always keep a lean, business-like approach in mind.
The tasks performed by me could be one of the following, by itself or combined:
  • Selecting sites for your research project, preparing each, setting up the logistics, contracts, and applying for regulatory approvals (EC and CA)
  • Central Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)
  • Quality Assurance when setting up your research project, build or refresh your Quality Management System (issue Monitoring Plan, Data Management Plan, etc.)
  • Data Management activities / (extended) Central Monitoring
  • Employ ACTRIS (see elsewhere) to manage any issues / potential risks
  • Train or coach other CRAs/monitors working on the same trial
  • Oversee Safety Reporting, provide follow-up if needed
  • Generally speaking, all the tasks described under item 5.18 of the E6 ICH-GCP guideline
    • In general, when submitting your trial to EudraCT, my name and details will get listed at section G5 of 'Annex 1 Clinical trial Application Form' (G5 sub items 1.9, 1.10, 1.11 and 1.13 answered 'yes').

Contact

On request, I can send you further information, such as a Curriculum Vitae, a recent copy of my training log, a publication list, or my ACRP credentials. Please contact me to have a chat, and to find out my current or future availability.

e.smeets@sic-est.nl
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