Clinical Data Management EDC CTMS Customer Case Study Clinical Operations Academic & Healthcare

The experiences of Parnassia Group

Safeguarding governance responsibility and better organizing research Daphne van Hoeken, Coordinator Mental Health Research, explains: “Because we are not an academic institution, research is not part of our core setup….

The experiences of Parnassia Group

Reading time:5 min

Posted:17 October 2023

Safeguarding governance responsibility and better organizing research

Daphne van Hoeken, Coordinator Mental Health Research, explains: “Because we are not an academic institution, research is not part of our core setup. To better support colleagues in our large organization who nevertheless have to or want to conduct research, there was a latent need for a supportive digital tool. The real trigger to actively look for one was a visit from the Health and Youth Care Inspectorate in 2017. It turned out that, at the governance level, we did not have a clear overview of which studies were running at that time and which patients were involved. We therefore wanted a tool that would allow us to properly safeguard that governance responsibility and organize the work for colleagues more effectively. We found that tool in ResearchManager.”

 

A CTMS tailored to our needs

One of the reasons Parnassia Group chose ResearchManager is the flexibility to configure the software entirely to our own needs. Van Hoeken: “We started with the CTMS and configured it together with ResearchManager. In doing so, we did encounter some shortcomings, because it became clear that our own processes were not yet in order. Clarifying those processes ultimately became part of the implementation, which was a very valuable side effect. During the project, I had regular and pleasant contact with ResearchManager. Their willingness to think along with us and help tailor the software to our needs was, and still is, very valuable. There was another reason we chose ResearchManager at the time: their easily accessible Dutch-speaking helpdesk. We are a healthcare organization, not an IT organization. Not all of our colleagues speak fluent English. The fact that we can always ask ResearchManager questions is extremely valuable to us.”

 

Streamlining the internal approval process

The CTMS has now been up and running within Parnassia Group for about four years. “The main goals we have already achieved? We now have a clear overview of all ongoing studies, and our internal approval process has been streamlined,” says Van Hoeken. “We now register all studies in the system, both studies reviewed by the Medical Ethics Review Committee and other studies involving patient data. When a researcher submits a study in the CTMS, the system automatically forwards the application to the appropriate executive. Submitting an application is quick and easy. In turn, the executive has a clear overview of which studies involve their patients, which studies have already been approved, and which still require action. This means the CTMS offers benefits for both researchers and executives. We also use the tool for internal promotion, as we can easily generate a report of all approved and ongoing studies. We regularly share this list on our intranet to inspire other colleagues. We like to make visible what is happening within Parnassia Group.”

 

The EDC and Patient Self Service

According to Van Hoeken, the EDC also offers significant advantages. “It provides a single central and secure location for collecting and recording our research data, excluding physical materials such as biological samples. Previously, this data was stored in various places on our servers, without a clear overview or proper management. This creates the risk that a researcher stores data in a personal location on the server, making it inaccessible if they leave the organization. That naturally makes you vulnerable as an organization. Although not all of our researchers use the EDC yet, we have already largely mitigated this risk. In addition, the Patient Self Service within the EDC is widely used. It allows researchers to send questionnaires to participants from the system at a chosen time in a fully automated way. The results are then automatically recorded in the EDC, eliminating the risk of errors. If a researcher modifies or adds data, that action is properly logged.”

 

A pleasant collaboration with ResearchManager

The questionnaires mentioned are built by Parnassia Group researchers themselves after a hands-on training. “These trainings are mainly followed by colleagues conducting research as part of their education. Timing is very important: ideally, people take the training when their research plan is clear and their questionnaires are ready. During the training, they learn how to build their own questionnaires in the EDC. Fortunately, more and more colleagues are now skilled in building questionnaires, so newcomers can always ask for internal support. It helps to consult a colleague with experience in mental health research. But thanks to their subject matter expertise, their willingness to think along, and the accessibility of the contact, working with ResearchManager is at least as pleasant. I would recommend it to anyone.”