Stability paves the way to success: How FGK, RHEACELL, and Viedoc powered a complex Phase IIb CVU trial during global pandemic

In a Phase IIb study for a treatment for Chronic Venous Ulcer (CVU), FGK managed 44 sites in Germany for RHEACELL.

RHEACELL, a fully-integrated biopharmaceutical company with over 20 years experience based in Heidelberg, Germany, develops innovative stem cell therapies for severe immune and inflammation-driven diseases with high unmet medical need. In addition to the application in chronic wounds, RHEACELL is also investigating the effect of stem cells in congenital and currently incurable severe skin diseases such as recessive dystrophic epidermolysis bullosa (RDEB).

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 in Germany, 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.

Thanks to the good cooperation of all those involved, this Phase IIb study was successfully carried out despite adverse circumstances.

The challenging patient population with very inconsistent wound care status 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.

• The close and fruitful cooperation with the sponsor and patient recruitment services brought further patients in all participating sites, but the main driving factor was the close partnership between project team and study sites. Through ongoing support by FGK, bureaucratic burdens were minimized and motivation was kept high.

• The challenge of efficient data capture for such a big patient pool by many contributing parties was met with the help of our FGK’s long established partner Viedoc, who provided an intuitive EDC tool which could be adjusted perfectly to fit the study requirements, even over the lengthy recruitment period of 3 ½ years.

• Another key to success was the continuous and fast responsive communication between all parties, resulting in fast decision-making and problem solving, e.g. adaptation of the eCRF requirements by FGKs internal eSolutions team supported by the consistently responsive team of Viedoc.

As the efficacy endpoints concentrated on wound closure and wound healing, many factors had to be monitored on a time sensitive basis, especially during the screening period. Also the wound status had to be documented by the site staff with challenging special equipment. By close supervision and support of the study team, this hurdle could be overcome.

The situation at hospitals and doctor's offices had been persistently tense since the start of the study due to the coronavirus pandemic. This also impacted the behavior of the patient population, which was generally older. To improve recruitment and ensure the conduct of the clinical study, FGK increased the number of participating study centers and added comprehensive advertising campaigns.

Due to the successfully completed previous/precursor studies, the challenges for the study team were clear right from the start. Therefore, the careful and structured planning for the study, together with all involved parties with constant constructive and focused exchanges led to a very successful outcome despite all the aforementioned difficulties.

Success often requires the right partner: For FGK, a reliable EDC partner like Viedoc solutions 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 intuitive and easy to use software solution from Viedoc, new study sites could be onboarded continuously and immediately started working on the projects efficiently. Currently a phase 3 study by RHEACELL is ongoing, together with FGK and Viedoc, and the aim is to achieve market authorization based on the data.

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