Paper is patient, so are we.
Working closely with the monitor to succeed
A project must align with us, say the Camovis employees with full conviction. When the intention behind it is right, it becomes much easier to dive into the work with full energy – even when time pressure and precision demand full throttle in the project, quite literally. Just like in a short-term project that a Clinical Research Organization had assigned to the Camovis team.
Data upon data, that’s probably the best way to summarize the project’s content. The doctor responsible for the study in a cardiology department had changed hospitals. During a visit by the monitor, it was discovered that the study records hadn’t been maintained since that point. With a retrospective view and a rapidly approaching deadline, all the data had to be captured to avoid protocol violations – and thereby jeopardizing the success of the study.
The subject of the study was a medical device implanted in patients with severe heart failure. The goal was to reduce the mortality rate and improve the quality of life for those affected. 22 individuals were included as patients in this study. Following the pilot study, the necessary data was collected over the span of 4 weeks, three, six, twelve, and 24 months. Always with the question in mind: How have the parameters evolved? Were there any unexpected events?
Two weeks, 40 hours each, were allocated to process all the files, filter the relevant information, and compile all the data. All study-specific paper records had to be filled out based on the electronic hospital records. Then, the use of a marker to redact patient information from doctor’s letters, which was crucial for data protection. After that, a trip to the copier and finally, filing. A colleague of the originally responsible CRA had to familiarize herself with the subject matter since he was on vacation at that time.
Today, the Flying Study Nurse proudly recounts her project. She processed patient records from two and a half years of study in just eight working days. This included complete data capture and, when necessary, “Data Correction.” All information was prepared for the doctors in such a way that ideally, they only needed to sign the documents. The feedback from the physicians was equally positive, as they were more than pleased that the Flying Study Nurse went above and beyond and took on all the tasks comprehensively.
As challenging and demanding as the effort was in terms of concentration and motivation, the project atmosphere was extremely positive, and the collaboration worked “seamlessly.” The attempt by the CRO to recruit her after the end of the joint project can certainly be understood as the highest compliment.
The employee remained loyal to Camovis. She is aware of the freedoms and opportunities that the company provides her – and that the values it portrays externally are lived internally as well. Just as in the selection of its projects. “Medical devices are always very intriguing as projects, as they serve a purpose. They can enhance the quality of life for affected individuals, enabling them to, for instance, walk their dog again using the device. It’s satisfying for us to contribute to that.”