Bridging the Gap between Bio-Pharmaceuticals,
CROs, Clinical Investigators and Trial Participants

Clinical Trial Documents

Bio-Pharmaceuticals and Clinical Investigators alike indicate that handling and tracking of all relevant Trial Documents is one of the major reasons for delays in Clinical Site approval and Study Startup.
The Clinical Study-Portal tools helps you to overcome this hurdle. First of all, by providing all relevant parties (Bio-Pharmaceutical or CRO employees, Investigators, Medical Ethical review Committee’s (MEC), Independent Review Boards (IRB)) easy access to the latest version of Study Documents.
Secondly, by making sure that each group or user only has online access the Documents which are relevant to them.

Trial Master Files (eTMF)

You can define individual layouts for each of your Trial Master Files, you can share TMF layouts over different studies or have individual TMF structures per trial. When a specific Site or Investigator wants to view their Site Trial Master File, all documents will be automatically filtered. Whereas a Sponsor will be able to access the Trial Master Files of each and every Site.

Users can be granted access to upload Documents directly into the Portal. Based on Security settings, these uploaded Documents will show up in the corresponding listing or need to be ‘approved’ by a Documents Administrator first.

Documents and more

When we refer to documents, actually we mean a lot more. A Document in the context of our Clinical Study portal can be anything, a document in the form of a .PDF file, a training video for Site Approval, a Powerpoint of your latest presentation, a set of pictures taken at your Investigator meeting, a faxed contract or even X-Ray files. Anything which can be stored as electronic file can be shared with other Users. And depending on User Settings, can also be uploaded to the Study Portal by Users.

How does it work?

In a nutshell, once a User has Upload access, he/she can upload Documents to the Portal. The Documents Admin can link Documents to any Project/Trial/Study to which they have access. In addition, Documents can be tagged (eg ‘linked’) to one or more Categories, like ‘Site Initialization’ or ‘Training Documents’. A Documents Administrator can design ‘Document Listing’ pages and set certain Categories to be displayed on each page. Access Rights define which Documents a user is allowed to view.
If a user, logged in to a specific Study, is accessing the ‘Training Documents’ page, he/she will able to view all Documents which have been llinked to that Study and which have been tagged with ‘Training Document’ and for which he/she has been granted access.
As Access is dependent on the ‘role’ a User has, a Bio-Pharmaceutical Employee might see a different subset of Training Docs than a Clinical Investigator might see. In fact, the Clinical Study-Portal can just as well be used to provide Documents or Information to your Trial Subjects.