The key challenges
The clinical trial included 13 sites globally, each of which required a specific ultrasound technology. Medical devices must comply with various regulations, both local and national – for example, the European Medical Device Regulation – and these are subject to change. Woodley Trial Solutions drew on its extensive regulatory knowledge to ensure the ultrasound systems were compliant for use at all the trial sites. A diverse range of system-specific accessories was also sourced, including tangible hardware – such as transducers, mobility carts, travel cases and battery packs – and various software packages. These were obtained from a number of third-party suppliers – as is often the case to meet special regulations for each country – ensuring that they were compliant and able to be used for the trial, and that all relevant documentation was in place prior to importation. Furthermore, the ultrasound equipment and accessories were carefully tested at each trial site. This made sure that all the devices were fully functional, and left in the optimal state to support the study and its patients.
A change of CRO
During the course of the trial, the study transferred from one CRO to another, as one phase came to an end and the next began. This called for the combined experience of Woodley Trial Solutions’ project management and contracts teams, who efficiently handled all internal communications, and quickly grasped the particularities of working with the new CRO. This smooth changeover was essential to ensure patient visits continued uninterrupted, technical support remained available, and unnecessary and expensive delays to the trial were avoided.
Woodley Trial Solutions sourced and supplied bespoke ultrasound equipment from a reputable manufacturer. The company ensured the equipment complied with all regulations, was accompanied by the required documentation to streamline shipping, and was approved for use in the clinical trial. Woodley Trial Solutions was also able to use its expertise in the field to ensure a smooth transition from one CRO to another, liaising with all parties involved to safeguard the uninterrupted continuation of the trial.