The design phase of a clinical study will start when the Clinical Research Services Agreement or LOI for this study is signed. During the design phase a kick-off meeting will take place. The objective of this meeting is to develop a shared vision for the fulfilment of the study from design to closure. It will ensure that critical success factors including goals, scope of work, timelines, roles and responsibilities, procedures, training, communication, expectations, and deliverables are clearly defined. Auxiliis’ Clinical Project Manager will be responsible for the organization, preparation and follow-up of this meeting.
The Auxiliis Clinical Project Manager will prepare the Project Plan to ensure proper organization and management of the study. The Project Plan will describe the study timelines, assumptions, objectives, responsibilities and organization and risk factors of the study. It will also discuss project communication (including meeting frequency), the involvement of third parties, and applicable procedures (SOPs). Auxiliis will discuss the Project Plan with the Sponsor, preferably during the kick-off meeting, after which the Plan will be finalized. The Project Plan will also include a Project Team Sheet including all assigned staff.
To every project a dedicated Project Team will be assigned, headed by one Clinical Project Manager. The Project Manager will assure that the Project Team is being trained and is conducting the project according to the contract and budget.