At the HUB, there isn’t one way to run a project – each study is unique and each partner has different needs. We recommend that you contact us for an initial consultation about your requirements so that we can better understand your project and how we can help.
We typically take our partners through the following steps:
DISCOVER, ENVISION, ADVISE
The initial consultation would include relevant members of the research team. Depending on the type of project, attendees could include members with expertise in methods, statistics, design, health economics, study operations, knowledge translation and budgets. This meeting is to help you refine your research question, consider endpoints, and begin thinking about some business and operational aspects of your proposed study.
DEFINE, COLLABORATE, STRATEGIZE
After the initial meeting, the HUB study team continues to work with you on protocol development. We help you identify sources of funding and to think about the logistics for your research study. This includes the consideration of potential participating sites, the scope of the HUB’s work, and incorporating any other infrastructure you might need.
PROPOSE, DOCUMENT, ENGAGE
Once the protocol begins to take shape a detailed breakdown of the project plan including scope of work, study protocol and pricing are communicated. The project plan clearly identifies responsibility of tasks and increases efficiency and compliance.
ASSIGN, IMPLEMENT, DELIVER
Once funding is received a project team, including a dedicated project manager, is assigned. Sites are contacted, site support is provided, case report forms are developed, and training is provided. The Informatics team develops, validates, and launches the electronic data capture system. Contracts, budgets, and other operational details are negotiated and finalized. If required regulatory submissions are made, sites are trained and the study is launched!
MEASURE, REPORT, MONITOR
The HUB team maintains close contact with the study Sponsor and study sites to ensure patients are enrolled and followed in the study and that quality data is collected. Data management activities include cleaning data and working with sites to address data queries. Required safety monitoring and committee meetings are organized and relevant metrics regarding study progress are communicated.
ASSESS, TRANSFER, CLOSEOUT
At the conclusion of the study, the study and sites are closed out, the analysis on the cleaned dataset is performed and results are disseminated. All study materials are transferred back to you.
We admit it. "Celebrate" is not really a step in the process but we do recommend that you throw a party to celebrate your accomplishments! Let us know...we'd be happy to join you!