Running a medical device or IVD clinical study involves dozens of activities across three phases: preparation, enrolment, and close-out. A team carries out the work, but someone has to know what must happen, when, and who is responsible. That is clinical project management, and it is the part of a study less experienced Study Sponsors most often underestimate. Sponsors who neither have this expertise in-house nor delegate it often take on risks they are not aware of. The consequences appear later as delays, extra costs, or data that may not support a regulatory submission.

Project management is the largest single line in most device and IVD study budgets, typically 30-40 % of the total. It is also the item sponsors question most often, usually because the proposal shows the cost but not the work behind it.

In this webinar, hosted by MedTech Leading Voice, the subject matter experts will be:

• Daniela Karrer, VP Operations and Clinical Affairs, Donawa Lifescience
• Matteo Mosso, Director, Clinical Affairs, Donawa Lifescience
• Elena Arcangeli, Clinical Project Manager, Enovis

Daniela and Matteo have managed over 100 device and IVD studies in the last ten years for Donawa Lifescience. In this webinar, they take the project management line apart and show the work inside it, using anonymized studies to highlight its importance. Elena adds a sponsor’s view, after three years’ partnering with Donawa Lifescience on a number of studies.

Topics to be covered include:

• What a CRO’s project management line typically covers, activity by activity
• Which sponsor decisions drive project management hours up
• Which decisions bring them down, before the study starts
• What a documented, traceable study file looks like from the inside

Further information can be obtained from LinkedIn.