A clinical development plan describes the clinical activities with your in the pre- and post-registration phase. And although it may seem a burden or a hassle, it also brings along opportunities. Connecting this plan and your marketing strategy for example offers a great opportunity to involve important stakeholders like KOLs in an early phase, define claims and obtain early experience with the clinical use of your device.
The clinical evaluation also describes the clinical post-registration activities. Post-market surveillance (PMS) is a general obligation and has multiple purposes like perfomance and safety confirmation, efficacy assessment and vigilance monitoring.
Whereas previously clinical outcomes research was limitedly performed, it may now mandatory in both the pre- and post-registration phase. On one hand to obtain registration and on the other hand as a PMS obligation in the from of a PMCF-study. Depending on the situation the clinical research can be relatively simple or complex and it requires knowledge and experience to understand which type of clinical research will answer the research question.
Medical Affairs is an established function in pharma but is not widely used in medical device companies. However, an experienced medical affairs group has the knowledge, expertise and skills to manage the clinical evaluation programme of a medical device. Lacidem can build on a broad medical affairs experience in both medical device and pharma companies, are aware of the differences between these businesses and know how to manage medical/ clinical programs for devices and pharmaceuticals.