PROJECT MANAGEMENT
Our team offers a full suite of services to optimize your trial.
This starts with a dedicated experienced project manager who acts as unique point of contact for your team, from North America to Europe and Asia.
Each project management expert assigned to the project coordinates and proactively monitors your study, rapidly resolves issues and adjusts processes as needed to anticipate any challenges and bottlenecks.
The project manager coordinates the activities of all relevant stakeholders, including experts and other support team members (technicians, data and device managers). They work closely with you to ensure a smooth and efficient execution of your project from setup to full trial completion.
Communication is key to the successful conduct of a project. Your project manager establishes a communication plan with your team to make sure all stakeholders remain aware of key milestones, deliverables, and progress – and any issues affecting those activities – during the course of the program.
An advanced study management workflow
We deployed our skills and methods of project management to fit with your timelines and specifications. At every step of the process we adapt and customize the effort of all ensuring key milestones are achieved:
1 Project set-up
a. Kick-off meeting
b. Data protocol standardization
c. Site qualification and training
d. Validate and elaborate testing hypothesis, modelling and preliminary analysis
e. Validation of study documentation : Scope of Work/ -Charter, image review charter / communication plan
2 Data integration
a. Data logistics and tracking
b. Comprehensive technical support
3 Data cleaning
a. Demographic data check
b. Data quality check
c. Query resolution
4 Data analysis
a. Comprehensive scientific support
b. Customized analysis routines developed (Simple or double data review)
c. Development of study-specific algorithm
5 Data transfer
a. Analysis of outliers
b. On-line report and fast turn-around
c. Database export
d. Statistical analysis
6 Project closure
a. Study closure & lessons learned
b. Data archiving
Commitments and guarantees
We build together the frame of actions and tasks to achieve the objectives of your project, from the drafting of the protocol to the closing of the study, ensuring compliance with the regulations in force and the latest innovative considerations.
Your dedicated study manager is committed to being your support throughout the study, as a member of your clinical study team.
Thanks to our expertise in cardiac safety, endpoint adjudication, imaging, eCOA/ePRO and virtual clinical trials, we provide your project with all the required services to successfully achieve your goal.
Quality and commitment are Banook’s intrinsic values. Our team is regularly trained in the new processes and regulations in force.
Thanks to our expertise in cardiac safety, endpoint adjudication, imaging, eCOA/ePRO and virtual clinical trials, we provide your project with all the required services to achieve successfully your goal.
Quality and commitment are Banook’s intrinsic values. Our team is regularly trained in the new processes and regulations in force.