Case study

How FGK, RHEACELL, and Viedoc powered a complex Phase IIb CVU trial during global pandemic

June 23, 2025

Conducting clinical trials for chronic venous ulcers (CVUs) is inherently complex—especially during a global pandemic. This case study explores how FGK Clinical Research, in close collaboration with RHEACELL and Viedoc, successfully powered a Phase IIb CVU trial by combining expert trial management, innovative stem cell therapy, and a flexible electronic data capture (EDC) system to overcome recruitment and operational challenges in a decentralized setting.

Challenge 

FGK was tasked with managing a large, long-term Phase IIb trial for RHEACELL, targeting chronic venous ulcer (CVU)—a condition involving a hard-to-reach patient population, high screening failure rates, and time-sensitive wound data. The trial was further complicated by the COVID-19 pandemic and the need for remote, decentralized site coordination.

Solution  

FGK partnered with Viedoc to implement a flexible and intuitive EDC platform that enabled continuous onboarding, remote site activation, and customized eCRF updates throughout the 3.5-year recruitment period. The strong collaboration between FGK, RHEACELL, and Viedoc ensured responsive support and streamlined communication. 

Result

The study successfully enrolled 159 patients across 44 sites. The seamless collaboration and digital infrastructure helped overcome recruitment and logistical hurdles and paved the way for an ongoing Phase III study—bringing RHEACELL's innovative stem cell therapy closer to regulatory approval and patient access.

Seamless clinical trials through partnership & innovation

FGK Clinical Research is a full-service CRO running clinical trials phase I-IV worldwide with all central services office-based in Munich. Owned and run by founder Martin Krauss and 3 Senior Directors, FGK is an expert in collaborations with Biotech and Medtech companies and has extensive experience in a wide range of indications. 240+ in house employees, own subsidiaries in Poland, Hungary, Czech Republic, UK and the US and a knowledge based on experience since 2002, contribute to the success even in challenging studies, e.g. in the field of rare diseases or Advanced New Therapies.   

However, success often requires the right partner: A reliable EDC partner like Viedoc is crucial for conducting clinical trials, especially under challenging conditions such as a pandemic or when dealing with rare patient populations. It ensures consistent and remote data collection, enabling seamless collaboration between study sites regardless of location. Thanks to the good cooperation of all those involved, this Phase IIb study was successfully carried out despite adverse circumstances. 

“We have been collaborating with FGK and their partner Viedoc for many years, and their professionalism, flexibility, and deep expertise have consistently exceeded our expectations. Especially in this study, a reliable and intuitive eCRF system like Viedoc was of great advantage and we highly value this partnership,” says Christoph Ganss, Founder & CEO of RHEACELL GmbH & Co. KG

About the trial

In a Phase IIb study for a treatment for Chronic Venous Ulcer (CVU), FGK managed 44 sites in Germany for RHEACELL, a fully-integrated biopharmaceutical company that develops innovative stem cell therapies for severe immune and inflammation-driven diseases with high unmet medical need. In order to develop a cell therapy for the treatment of CVU, RHEACELL started a collaboration with FGK as a full-service CRO to conduct phase 1 to phase 3 clinical studies in patients with CVU. For this IIb study, 344 patients were screened and 159 enrolled within 38 months, with the help of a solid study team and an all-encompassing eCRF solution by Viedoc. 

The study faced several challenges. The patient population had a very inconsistent wound care status, which resulted in a high drop-out rate during the screening phase. Therefore, a high number of screened patients was necessary to reach the recruitment goal. 

“Given the timing (global pandemic) and rarity of our patient population, approximately 70% of screened patients did not meet the study requirements, so reaching the required number of patients was a significant challenge, not foreseen by the sponsor or investigators,” says Ursula Merz, Project Manager at FGK. 

To address the recruitment difficulties, the close and fruitful cooperation with the sponsor and patient recruitment services helped bring in further patients across all participating sites. However, the main driving factor was the strong partnership between the project team and study sites. Through ongoing support by FGK, bureaucratic burdens were minimized and motivation remained high. 

Female lab technician looking into microscope
Viedoc Clinic user interface

Adding value the Viedoc way

The challenge of efficient data capture for such a large patient pool, with many contributing parties, was met with the help of FGK’s long-established partner Viedoc. Their intuitive EDC tool could be adjusted to fit the study requirements—even over the lengthy recruitment period of 3½ years. 

Another key to success was the continuous and fast-responsive communication between all parties. This enabled quick decision-making and effective problem solving, such as adapting the eCRF requirements through FGK’s internal eSolutions team, supported by the consistently responsive Viedoc team. 

“The professional collaboration, open communication, and shared commitment with the sponsor RHEACELL, the reliable eCRF by Viedoc as well as the prosperous collaboration with the centers, contributed significantly to the success of the project”, says Ursula Merz. 

Project outcome  

Due to the successfully completed previous/precursor studies, the challenges for the study team were clear right from the start. Careful and structured planning—combined with close collaboration among all involved parties—enabled the study to succeed despite the many hurdles faced during its execution. 

Thanks to the intuitive and easy to use Viedoc eClinical solution, new study sites could be onboarded continuously and immediately started working on the projects efficiently. Following the successful completion of the Phase IIb study, FGK and Viedoc are now supporting RHEACELL in an ongoing Phase III trial—bringing this innovative cell therapy one step closer to patients. 

Looking to improve clinical trial efficiency with digital tools? Learn how Viedoc’s EDC system and eCRF software support streamlined data collection, remote site management, and patient-centric trial design. 

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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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