A clinical trial kickoff meeting (KOM) is an in-pe
Post# of 148101
Communicate information
The meeting provides a platform for sharing information about the study, including its rationale, timelines, expectations, and feasibility.
Set milestones
The meeting is an opportunity to establish milestones and allocate resources.
Build rapport
The meeting helps to build relationships between the regulatory agencies and pharmaceutical companies.
Identify challenges
The meeting provides a chance to address potential challenges and identify issues early on.
A KOM typically includes representatives from the sponsor and the CRO, and may also include a medical monitor. The meeting agenda is usually created by the CRO Clinical Trial Manager (CTM) and the Sponsor representative, and is approved by the Sponsor before the meeting.
Some tips for conducting an effective KOM include:
Providing a complete or stable protocol
Estimating any expected changes to the protocol and their potential impact
Reviewing the budget and payment schedule