CASE STUDY
- Assignment period: 4 years
- Locations: 2 sites
- Focus areas: patient recruitment, study coordination, clinical operations, data handling
Summary
In an international, multicenter clinical study for the treatment of therapy-resistant chronic venous ulcers, Camovis supported two study sites across multiple study phases with continuous operational responsibility. After a pPhase IIb study, Camovis also oversaw the subsequent phase III study at the same sites.
Our Flying Research Professionals ensured continuous study coordination, execution, and documentation, thereby contributing significantly to the successful implementation of both studies.
Initial situation
The studies were conducted at two clinical trial sites where patient care was the clear priority. Study-related tasks were supported by designated contact persons, but there was no firmly established, continuously available study team on site. Patient recruitment took place under real-world care conditions and was overall limited. Suitable patients had to be actively identified, as standardized recruitment pathways and existing patient pools were only partially available. To ensure structured study operations under these circumstances, continuous operational presence and coordination were essential.
Deployment of Flying Research Professionals
Throughout both studies, Camovis provided Flying Research Professionals who integrated seamlessly into the workflows of the trial sites and took on central operational tasks.
These included, among others:
- Identification and active prescreening of suitable patients
- Coordination of study procedures, appointments, and monitoring visits
- Planning and conduct of study visits
- Documentation, data entry, and data cleaning
- Serving as the central interface between trial sites, CRAs, and other project stakeholders
Outcome
Across both studies, study operations at the trial sites were reliably maintained. In particular, the monitoring team highlighted the structured organization, high data quality, and dependable operational execution.
