A lot is at stake in a clinical development project – medical research is a high-visibility, capital-intensive investment with major implications for sponsors, patients, and everyone in between. Whether a research program takes place over many years or for a few months, achieving project goals begins with a well-executed project kickoff meeting (KOM) between stakeholders. To help springboard clinical research projects to success, consider these five characteristics of effective kickoff meetings.

Include all key stakeholders and outline roles

This can be an overlooked aspect of any meeting – having the right people at the (physical or virtual) table is crucial to ensure the proper scope and design are achieved, and to avoid potential delays further downstream. Kickoff meetings for projects with Signant might include ten to fifteen people depending on the nature of the project. For each project team, we recommend at least one of the following: senior scientific advisor, project manager, solution architect, project specialist, application specialist, data manager, business analyst, and verification specialist. For sponsors and CROs, their project teams can include sourcing specialists, data science, clinical operations trial lead, and a global medical lead, as well as the CRO’s clinical trial manager. In the meeting documentation, include everyone’s name as well as their role to provide clarity as to who is responsible for which aspects of the project.

Include an agenda

Another important aspect of any meeting, the agenda is a foundational component that ensures all participants will leave the meeting having addressed their goals and priorities for the project. Always include an agenda in the meeting invitation. It can be helpful to send the agenda to stakeholders in advance and request their feedback. This can also help project teams understand each stakeholder’s priorities. Begin the meeting with a review of the agenda.

Bring a complete or stable protocol

Everything is dependent on the clinical trial protocol, so it is important to provide your project partners with a complete or eCOA-stable protocol. If it is not finalized at the time of kickoff, provide an estimation of what changes are expected to come, and if those changes will affect the eCOA build. Changes to protocols after a KOM takes place can result in schedule delays and changes in scope that may require additional, unforeseen costs.

Dedicate time to reviewing schedule

The project team should review the protocol’s details with respect to the screening, treatment, and follow-up period including specific FPFV and LPLV dates. This provides the framework a project manager needs to develop a detailed project schedule with dependencies and milestones needed for each task within the software development lifecycle as well as the overall project lifecycle. As part of the KOM and subsequent project meetings, we review potential risks and build contingency plans in collaboration with the project team.

Establish next steps

At the end of the KOM, outline next steps to delineate what will happen next and who will be responsible for each task. For example, determine when the team can expect to receive the project plan, who will coordinate schedules for the next meetings, and how frequently they will occur. Set expectations as to when the next meeting will be, who should be involved, and what must be accomplished prior to and in that meeting. This will help keep communications smooth and ensure everyone is on track. And don’t forget, when scheduling your next meeting, establish and get consensus on the agenda.

These recommendations can apply to most meetings, not just those billed as project kickoffs or for clinical research. Try some and let us know if you achieve better results by tagging us on LinkedIn or Twitter using the handle @SignantHealth.

Contributing Authors: Carolyn Mace, Chanel Cooper, Nick Gambino, Brandy Morneau

Carolyn Mace

Senior Implementation Project Manager

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