Case study

Clinfidence and Citryll rely on Viedoc to complete complex Phase 1 trial and launch Phase 2

Challenge 

To support the data collection for a complex, multi-stage Phase 1 trial for one of Citryll’s lead drug candidates, Clinfidence built an eCRF. The trial was initially designed as a healthy volunteer trial. Staying in control was complicated by the approval of various protocol amendments during the trial, requiring implementation of new eCRF design versions within a short timeframe. 

Solution  

Clinfidence used Viedoc to set up the initial eCRF design and implement all new eCRF design versions based on the protocol amendments. For the group of RA patients a DAS score calculation was added to the eCRF design to reduce the risk of calculation errors. The short communication lines between Citryll, Clinfidence, and Viedoc ensured that the manageability of the data collection remained guaranteed.

Result

By validating the safety and pharmacodynamic profile and bioavailability of the treatment, the trial results helped secure funding for a second-phase trial. Using Viedoc also saved up to 30% of the eCRF setup time for the Phase 2a trial in patients with moderately active RA by using the eCRF design of the Phase 1 as a template.

February 26, 2026

Biotech pioneer Citryll partnered with CRO and data management experts Clinfidence for a phase 1 trial of a new therapy focused on Rheumatoid Arthritis (RA) and Hidradenitis Suppurativa (HS). The four-stage trial involved over 80 participants at two sites in the Netherlands, and the rolling nature of the trial meant that the results of one stage impacted decisions about the following stage. Viedoc’s Clinic's usability, speed, and automation minimized risk, ensured accuracy through numerous mid-study changes, and accelerated Phase 2 setup.

A complex clinical trial tests a breakthrough approach to inflammatory disease 

Inflammation is a crucial factor in immune-mediated diseases, and a Netherlands-based biotech company, Citryll, is focused on developing an innovative treatment. Citryll targets extracellular traps (ETs) as fundamental drivers of inflammation leading to Rheumatoid Arthritis and Hidradenitis Suppurativa. 

Working with CRO Clinfidence, the Phase 1 trial for this novel therapy involved four interdependent stages, where the outcome of one stage influences the next. Taming this complexity relied on Clinfidence’s significant data management expertise and the need for long-term accuracy. 

These factors also made a versatile EDC solution essential for success. Clinfidence selected Viedoc as its EDC platform for the trial, which involved over 80 participants at two sites in the Netherlands. 
 

Partnering for speed, accuracy, and simplicity 

As Citryll’s head of clinical development activities, Leonie Middelink, explained, “There are multiple diseases we can target with this new therapeutic—inflammatory diseases, autoimmune diseases. That’s why this trial is so important, and so is having the right partnerships.” 

That includes selecting the right data platform provider, Clinfidence founder, Nicole Spelier, explained. In particular, she explained, Viedoc’s efficient handling of changes proved critical, as the trial's rolling nature led to 17 mid-study changes, most of which were based on protocol amendments. Viedoc easily adapted to these changes without slowing down the trial team, ensuring the data remained complete and accurate.

Leonie added that Viedoc offers another significant advantage to trial teams: speed of access. “Having the data in real time and making it easy for my colleagues to explore lab data and analytics helped shape our thinking around certain adverse reactions. Viedoc has never been the limiting factor time-wise,” she said.

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Viedoc is the foundation for informed decision-making 

For multi-part, multi-site studies like this one, data entry and data access challenges can impact time-sensitive decisions. Viedoc simplified these functions, minimizing risk and giving leadership confidence in the data.

Clinfidence used an automated DAS score calculation for the trial, simplifying a key process. According to Gerald Ruiter, Clinfidence’s Director of Data Management, “It's completely automated by default. There are many complex calculations to be performed, and you don't want the site running them outside the system. That would add too much risk of data entry and calculation errors. I think the automation was a big win.”

Leonie found that Viedoc also delivered a huge positive effect on decision-making, as the system enabled direct access to the data, such as safety and demographics details, in a highly structured way. 

Overall, Leonie said that Viedoc was both highly effective and well-received by users across the trial. “One of our project managers, who's been working in clinical research for over 15 years, said, ‘This is one of the best systems I've ever worked with.’ The same goes for me.”

Collaboration drives faster, more effective support and problem-solving 

Each member of the team supported the others, delivering rapid resolutions to any challenges along the way. Leonie praised Clinfidence’s problem-solving skills, saying the support team can basically solve any issue or question that arises.

Both Gerald and Nicole agreed that Viedoc’s support was always effective. As Nicole put it, “It's good to have both a responsive team for the technical support and our dedicated Customer Success Manager for any other questions.” 

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Continuing the partnership and accelerating Phase 2 startup 

The success of the Phase 1 trial led directly to funding for Phase 2, which is currently underway. The partnership between Citryll, Clinfidence, and Viedoc continues, and in fact, using Viedoc had a substantial impact on shrinking the startup time for Phase 2.

According to Gerald, reusing the templates from Phase 1 saved 20 to 30% of setup time, which was crucial, as the timing for Phase 2 was very tight. This also benefits the site teams, he added, as they are familiar with the interface and confident in its operation. As Gerald put it,“ For Clinfidence, Viedoc is the system to use, and we don't use other systems.” 

 

It's a user friendly EDC with ease of implementing changes. The customer support is quick. I use it frequently for studies. There are multiple features compared to other EDC which provide ease of integration of all the expectation.

Ankit S.

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October 06, 2023

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