Investigators want to be able
to communicate with their Peers

How does the Study-Portal facilitate Community Management?

The Study Portal is built from the ground to facilitate Community Management. We use the latest in Social Media tools to facilitate the communication process between all participants in a Clinical Trial (Sponsor, CRO, Clinical Sites and Trial Subjects).
Like when an investigator has a particular question, he or she can either find the phone in the profile of the Bio-Pharmaceutical employee or leave a message for the employee using the Portal software.

We have Investigators participating in multiple studies. How does your system handle this?

The Portal is designed to handle multiple Studies. So you have a ‘pool’ of Users which can be linked to one or more Studies. And if you have a User Profile of a Clinical Investigator, that Profile automatically becomes available in each Study in which the Investigator is authorized.

Some of our Documents are confidential. Do all Users have access to all Documents?

No. First of all, Documents can be linked to one or more Studies. Secondly, viewing of Documents can be regulated by the ‘role’ a User has in a Trial. And you can even set Access at the User level.
As an example, if you have Non-Disclosure Agreements between the Sponsor and each site, you could define that only Users with the role of ‘Pharmaceutical Employee’ have access to such Documents. Plus add an additional rule specifying that for the NDA of site A, the investigator of site A has access (and the same for the NDA of site B).

Can we use the Study-Portal to inform potential Subjects on the Eligibility criteria for this study?

Yes, certainly. The best way would be to add a ‘public’ section to the secured portal. This can then be used to inform potential Subjects on the purpose of your study and the eligibility criteria.
Additionally, you can add a contact Form and forward their contact details to the closest Site.

How can we use the Study-Portal to inform enrolled Patients?

You probably don’t want to address Patients or Subject individually. In this case there is no need to create individual accounts for each patient. So you can create a single ‘Patient’ account and supply the Username and Password to each of your Subjects. By setting the proper Access Rights, they will only be able to view content which is intended for the group of Patients.
As Patients sometimes have difficulty explaining the purpose of a trial to their next of kin, it has proven valuable to add a general section explaining the purpose of your study. And possibly any intermediate results.

What if a Trial Patient reports an Adverse Event using one of your tools?

Yes, this might happen. we have explained this in more detail in a Blog Post.

Is there an option to use the Study-Portal to present individualised Reports for each Subject in a Trial?

Yes, this would require that each patient has its own account. Upon login, the Study-Portal then knows which User has logged in and will be able to display the proper report for each Subject.