Case Study 3: Assistance Required – New Medical Device VentureThe Challenge If you’ve just started your clinical trial program, how do you manage global studies from one office with only a few staff, busy doing many things at once? A recently started device company at the time approached BELTAS for assistance. They had a busy trial program with tight timelines. Besides site management, advice was needed about the regulatory processes in several countries and help with site communication. As a fast-growing company, they were integrating a lot of new personnel and procedures. The Response 1. BELTAS established regular contact with the client to stay in tune with the latest developments at the company. At the same time, we kept sites informed about important trial matters without overloading them with information. 2. We acted as the point of contact for sites, which minimised the disruption of client growth on the trial program. We also kept change in our team to a minimum, which provided stability for both the sites and the client, during a period of rapid expansion. 3. In being involved with the client’s program from the start, BELTAS was able to rapidly pick up and respond on changes in protocol, data handling procedures etc, allowing adaptive clinical trials as data came in to guide the development program.
4. Flexibility and a ‘can-do’ attitude were key in dealing with the many changes during trials. The excitement of being involved in a new technology is great, as is working with a variety of new people with new views and ways of working. • Through close communication with the client and sites, BELTAS has repeatedly met recruitment and data collection timelines in Australasia and in Europe Client Feedback “You’ve been right on top of it. It’s a tribute to your monitors”
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"You've been right on top of it. It's a tribute to your monitors" - Client Clinical Trial Manager |
