A clinical development plan, as part of the clinical evaluation, details what should be done clinically and how this should be organised in both the pre- and post-registration phase. Connecting this to your marketing strategy offers a huge opportunity to align with important stakeholders (eg KOLs), define claims and obtain early experience with the use of a new product in an early development stage!
The clinical evaluation also describes the clinical post-registration activities. Post-market Surveillance (PMS) is a general obligation and has multiple purposes like safety monitoring, efficacy demonstration and of course regulatory maintenance.
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. 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 and expertise to manage the clinical evaluation programme of a medical device company.
At Lacidem we have experience in both pharma and medical device companies. We are aware of the differences between these businesses and know how to manage clinical evaluations and developments in both.