- It’s the same as building a study in Oslo.

Smerud Medical Research Group (SMERUD) has been part of the clinical research organization (CRO) market for almost 30 years. Providing full-service clinical trial services to academic, pharma, Biotech, and MedTech sponsors throughout Northern Europe and the UK, they specialize in mainly Phase I and Phase II studies.

While SMERUD is based in the Nordics, the group assists sponsors with studies recruiting participants in remote destinations such as Brazil. How do they do this successfully?

We sat down with Charlotte Kleiveland, Chief Operating Officer at SMERUD, and Ana Teresa Holsether, one of SMERUD’s data managers, to learn the answer to our question and find out how this CRO manages studies—over 2000 projects to date—around the world.

It turns out the answer is simpler than you might expect. Data collection is conducted online via the Viedoc eClinical suite and supplemented with Viedoc Me, an ePRO/eCOA module which allows participants to enter information on the platform directly—through smartphones, tablets, or computers. This eliminates the need for most in-person visits, increasing the rate of participation. Not only does this method make participants more comfortable, but it also makes data collection seamless and adaptable, so studies can be conducted across the globe.

But how does Viedoc Me work exactly and how does it work so seamlessly? The ePRO turns data collection into an engaging activity for the participant rather than a daily chore. The questionnaire can be completed easily—it’s just a matter of questions and answers. Ana praises the simplicity of this system for data management.

- It’s easy—the setup. It’s the same as building a study in Oslo.

When a research group contacted SMERUD asking if they could support data management for a vaccine study in Brazil, they were able to take on the project, thanks to their small size and Viedoc’s capabilities.

- They were in need of someone who can turn this around quite quickly and, in the end, Ana built the eCRF in a week or so.

Implementing Viedoc in remote areas

Although healthy patients were required for this vaccine trial, it was integral to the study that prospective patients had access to the internet via computers or smartphones. As Brazil remains a country facing extreme economic inequality, Charlotte was understandably concerned that this could prove a real barrier to the trial.

- I think our question to our sponsor in Brazil, when they started to discuss the use of the ePRO was regarding the use of smartphones in the general population and whether we could expect everyone to have access to computers or smartphones or to be able to reply on an electronic device—or whether we needed a paper backup system.

With Viedoc Me, participants in a given study receive notifications like an SMS or email on their phone at a certain time each day to remind them to provide needed feedback. If participants can access the internet in some way, they can participate in a study with Viedoc’s platform.

- The feedback we got was that even if they didn't have a roof over their head, they had a smartphone. And I think there's very few now that are missing diary entries. We haven’t gotten any feedback that there have been any issues of people not having access to electronic devices that makes them unable to respond to the eDiary.

SMERUD implemented the subject diary, or ePRO, during this vaccine trial to collect data on whether participants are experiencing side effects, which requires daily feedback. To ensure they get that feedback, they set Viedoc Me reminders, which can easily be configured in the platform. Each reminder or multiple reminders can be personalized and sent on a target date or a certain number of days before or after the target date. Moreover, the reminder will be set to the participant’s time zone, minimizing potential confusion.

- So, if they haven't completed today's diary in a certain time, they will get the reminder that they need to complete it. And then if they don't do it within the time, they get the reminder "please remember to complete your diary". They do this until they go to the next visit at the clinic, and then there is a new period where they get another set of questions. And in total, they are then completing a diary every day for 28 days.

Building global studies with Viedoc

In Viedoc Designer, it’s easy to set a default language when setting up the study design with multiple languages—48 of them, in fact—available for translation. This means successfully setting up a study in remote places like Brazil is quite manageable. How do these features benefit data managers like Ana?

- The fact that we can have this diary in the local language, in Portuguese—because I believe not many people there speak English—so the users or the patients can see the questions in their local language, and we receive them in English, is crucial. And we know what they’re answering right away, so that’s very helpful.

Viedoc offers a range of solutions that reach everyone involved in a clinical trial, from the participants in remote areas of the world to the data managers who ensure their data is valuable and secure.

Charlotte reiterates that the process of setting up such studies—global or local—is similar and quite simple.

Public health has been brought to the forefront in a world rattled by the pandemic. As Charlotte notes, the pandemic has also prompted a shift in the way we communicate, and thus, the way data is collected for clinical trials. With the growth of video conference tools, clinical trial participants are already used to such methods of communication.

Studies are no longer limited to the location they’re based in, and now we can go just about anywhere, thanks to EDC systems like Viedoc. Working toward a healthier world should be a priority everywhere, from the Nordics to Brazil. When equipped with the capabilities of Viedoc Me, there are no barriers—so we can go farther.